A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers
Phase: NA
Conditions: Hypertension, Arthritis, Coronary Artery Disease, Hepatitis, Diabetes, Asthma, Hyperlipidemia, HIV
Sponsor: Emory University

 
 
 
The Health Access and Recovery Peer Program (HARP) 
IRB#00047631 
 
Peer-Led, Medical Disease Self-Management Program for Mental Health 
Consumers 
 
 
 
 
The Health Access and Recovery Peer Program (HARP) 
 
 
 
NCT01725815 
 
Protocol Dated: 10/26/2010 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
I. INTRODUCTION TO THE REVISED APPLICATION 
 
We greatly appreciate the thoughtful comments by the reviewers, as well as the reviewers’ enthusiasm 
about the high public health significance of the proposed project.  Extensive modifications were made in 
response to these comments, which we believe considerably strengthen the application and will add to the 
study’s scientific and public health impact.  The following section briefly summarizes those changes:  
 
1. Representativeness of group participants and peer educators:  “The study will take place in the 
context of an organization of consumers who have sought group-based peer-led services…raising 
questions as to the generalizability to routine community mental health center settings.”  In response to 
this important concern, the application now proposes a multisite study that would recruit subjects across 
four diverse community mental health clinics throughout metro Atlanta rather than from the Georgia 
Mental Health Consumer Network. (IIIC4)   
 
“Given the requirements listed for the peer specialists to be trained and retain their position, there 
is some doubt that the individuals qualifying for this role will in fact have the same severity of mental 
illness as the treatment participants.”   We have dropped the requirement that the interventionists be 
certified peer specialists at the time they are recruited. Instead, peer educators will be chosen using 
the identical selection criteria as subjects participating in the groups.  As part of the initial training, the 
Georgia Mental Health Consumer Network will provide additional instruction to allow the 
interventionists to become certified peer specialists, (IIIC6f) which will allow them to bill for services 
during the dissemination phase (IV).  
 
2. Peer relapse: “A plan is not evident for when peer specialists relapse.”  We now describe 
strategies for addressing this possibility in the text (IIIC6f) and in the human subjects section (VIID3b). 
 
3.  More detailed description of pilot data:“The pilot study is not adequately described.”  We now more fully 
describe the initial pilot study, whose results have recently been published in Schizophrenia Research,1 (IIIC1d).  
We also conducted a second pilot study since the last submission to test a recruitment strategy designed to 
enhance engagement and retention in the program (IIIC1e).  Together, these studies demonstrated high rates 
of engagement, retention, fidelity, and the potential for improving improved clinical outcomes to as great or 
greater an extent than in general medical populations.  We believe these data provide a strong foundation and 
rationale for the full-scale study proposed in this application. 
 
4. Study outcomes and power calculations: “Better rationale for study outcomes, as well as power 
analysis for a broader set of outcomes… it is not likely the [physical fitness outcomes] would 
change...” We have better clarified the rationale for choosing the study outcomes; the number of 
outcome measures has been streamlined and the fitness outcomes have been removed.  (IIID3). 
Power calculations are now provided for a broader range of outcomes (IIID4d); based on these new 
calculations and the proposed sample size has been increased from 300 to 400.   
 
5. Optimizing engagement and retention in the intervention group: “Participants in the intervention group 
will be paid $20 for attending five of the six sessions of the intervention, raising questions 
of…generalizability...”  We have dropped the plan to pay consumers to attend sessions (subjects were not paid 
for attending sessions in either of the pilot studies).  Instead we are proposing a strategy that couples an initial 
informational session coupled with reminders from the peer educator prior to each group (section IIIC5a).  In 
the second pilot, this approach resulted in high rates of participation, engagement, and retention in groups.  
 
6. Other methodological clarifications: “Several issues in the methods…randomization procedures, 
masking or retention (particularly for control group). Data collection/data collectors.”  We have now more 
clearly specified details around each of these important methodological considerations (IIIC5, IIID2). 
“More detail needed about supports and contacts between sessions, how many people will be in each 
group, how long individuals will have to wait for groups to start…” We now provide greater detail about 
the contacts between sessions with other peers (IIIC6b2) the numbers of participants in each group (8-
12 members; see section IIIC6a), and the use of rolling recruitment to minimize wait times for 
enrollment (anticipated to be less than three weeks: section IIIC5a).   
 
7. Qualitative substudy:  “The qualitative analysis plan …is less well-specified than other parts 
of the application.”  We agree that this was underspecified and have removed it from the modified 
proposal to allow more attention to the expanded quantitative study. 
 
Because of these major changes, as well as the move to a shorter format, nearly the whole 
application has been rewritten and thus revisions are not highlighted in the text.

 
 
 
II. SPECIFIC AIMS 
IIA. Introduction 
 
Persons with serious mental illnesses (SMI) face elevated rates of chronic medical illnesses, and a more 
than twofold elevation in preventable mortality caused by those medical conditions.  Despite growing alarm in 
the mental health consumer community about these statistics, persons with SMI currently have few tools 
available to help them to effectively manage their medical conditions. 
 
In general populations, peer-led disease self-management interventions have been demonstrated to lead 
to sustained improvements in self-management and health outcomes. The most widely tested and used 
management program is the Chronic Disease Self-Management Program (CDSMP) developed at the Stanford 
Patient Center by Kate Lorig and colleagues.    With funding from an R34 intervention development grant from 
NIMH, the study team has developed and piloted a modified version of the CDSMP, called the Health and 
Recovery Peer Program (HARP), to be delivered by mental health consumers to mental health consumers.  
The theoretical model underlying the intervention, the Information-Motivation-Behavior Model, suggests that 
gaps in health knowledge, motivation, and behavioral activation make it necessary to modify the CDSMP to 
use it in persons with SMI --both group members and group leaders), and guided the adaptation process. 
 
Two pilot tests of the HARP program demonstrated that the program can be implemented with high 
engagement, retention, and program fidelity, and can result in improvements across a range of outcomes 
comparable to or greater than those seen in general medical populations.  This application now proposes to 
perform a fully powered, multisite trial of HARP.  This new study will make it possible to establish this new 
intervention as an evidence-based practice, while providing an understanding of the settings and populations 
where it may provide the greatest benefits. 
 
A total of 400 individuals with serious mental illnesses and one or more chronic medical condition 
(hypertension; heart disease; arthritis; diabetes; or asthma/COPD) will be recruited from four diverse 
community mental health clinics in the Atlanta metro region and randomized to HARP or usual care.  For 
individuals in HARP, two peer educators with SMI and one or more medical comorbid condition will implement 
a six-session manualized intervention over six consecutive weeks (one session per week). Peer educators will 
receive training through the Stanford CDSMP and through the Georgia Consumer Mental Health Consumer 
Network, which will provide additional instruction to allow peers to become certified mental health peer 
specialists.  Follow-up interviews and chart reviews at 3 months, 6 months (primary endpoint) and one-year 
post-intervention will assess clinical outcomes, improvement in generic and disease-specific measures of 
illness self-management, and quality of care.  
 
During the final year of the study, group participants will be trained to lead HARP groups, which will lay 
the groundwork for dissemination efforts. These efforts will build on the nationwide CDSMP infrastructure.  
Peer-led services can be reimbursed under Medicaid in a large and growing number of states, providing a 
potential funding mechanism for these efforts.   
 
IIB: Study Aims and Hypotheses: 
Study Aim 1: To study the impact of HARP on health outcomes 
H1. As compared with participants referred to usual care, participants in HARP will show greater improvement 
on validated measures of physical health-related quality of life, disability, and recovery. 
Study Aim 2: To study the impact of HARP on quality of disease management and medical care. 
H2: As compared with participants referred to usual care, participants in HARP will show greater improvement 
on validated measures of behavioral activation, generic and disease-specific self-management, and quality of 
medical care.  
Study Aim 3: To understand subpopulations in which the intervention is most and least useful (moderation) 
and to understand the mechanisms underlying the effectiveness of the intervention (mediation).  
H3: Persons with medical and social vulnerability will show differentially greater improvement from HARP than 
non-vulnerable populations; information and motivation will mediate the impact of the intervention on disease 
self-management. 
 
There is an urgent need to develop effective, scalable interventions to address the high rates of medical co-
morbidity and premature mortality among persons with serious mental illnesses.  If successful, this study will 
establish and lay the groundwork for disseminating the first evidence-based, fully peer-led intervention for 
improving physical self-management in this vulnerable population.  

 
 
 
III. RESEARCH STRATEGY 
IIIA. Significance 
 
A literature extending back more than 70 years has demonstrated the high rates of medical morbidity 
and excess mortality in persons with serious mental disorders.2 Mental disorders are risk factors for elevated 
rates for nearly every type of medical illness,3, 4 including cardiovascular disease, diabetes, and pulmonary 
conditions5-11  Mortality due to general medical conditions is elevated by two to three times in persons with 
serious mental  disorders,12, 13  and this differential mortality gap appears to be increasing over time.14.15   
 
There has been a growing sense of urgency among mental health consumer leaders about this 
epidemic of medical morbidity and premature mortality.16  However, to date, consumers have not had the tools 
available to address physical health and healthcare as part of their broader efforts to promote mental health 
recovery.17 Mental health consumers are becoming playing an increasingly important role in the mental health 
workforce, and 26 state Medicaid programs directly reimburse consumers as service providers.16 Given the low 
cost of these services, states’ growing interest in recovery-based approaches to care, and the expansion of 
Medicaid under health reform, these trends are likely to accelerate in coming years. 
There is now an opportunity to directly engage mental health consumers in improving physical health 
and well-being.  The Health and Recovery Peer program (HARP), developed in close collaboration with the 
creator of the nation’s leading disease self-management program and mental health consumer leaders, has 
the potential to improve medical illness self-management among a group of hard-to-reach individuals who are 
commonly underserved by the formal healthcare system.  The values of wellness and self-management 
promoted by the program are highly compatible with the recovery-based orientation of the mental health 
consumer movement. 17 
The public health significance of the application and its centrality to NIMH’s goals are underscored by 
the introduction to the NIMH strategic plan. “NIMH must measure success by ‘outcomes’: how well the 
research we support provides the evidence base…to enhance recovery for those affected, serve diverse and 
previously under-served populations, and reduce premature mortality among persons with mental illness.” 18  It 
addresses Goal 3 of the Strategic Plan, “Strategic Objective 3: Develop New and Better Interventions for 
Mental Disorders that Incorporate the Diverse Needs and Circumstances of People with Mental Illness,” and 
also Goal 4, “Strengthen the Public Health Impact of NIMH-Supported Research.” 
 
IIIB. Innovation 
Although there is a growing literature on the use of peer-led models to address recovery and mental 
health symptoms among individuals with serious mental disorders, 19-22 we are not aware of any peer-led 
interventions that address management of physical illnesses in this vulnerable population.  The current study 
will establish a new evidence-based program for improving management of chronic medical conditions that is 
delivered by mental health consumers to fellow consumers.  This approach has the potential to change the 
paradigm of healthcare delivery for this population, shifting from a professionally-driven approach to one that 
more actively engages consumers in their own health and wellbeing. 
The dissemination plan (section IV), which uses a pyramidal approach in which graduates of the 
program train leaders to run groups, will provide an innovative model for disseminating the intervention, and 
further enhance its public health impact. 
 
IIIC. Approach 
IIIC1. Overview of the Chronic Disease Self-Management Program, Adaptation, and Preliminary Data 
IIIC1a. The Chronic Disease Self-Management Program (CDSMP): Overview and Evidence of Effectiveness in 
General Populations The intervention builds on the Chronic Disease Self Management Program (CDSMP), the 
most widely established peer-led program for improving chronic illness self-management in general medical 
populations.  23, 24 CDSMP groups are led by two peer educators with chronic medical conditions; any given 
group includes participants with a range of chronic conditions such as diabetes and arthritis.  A series of six 
group sessions delivered over 6 weeks addresses self-management tasks found to be common across chronic 
health conditions. 25-27  The CDSMP has shown to improve disease self management, health service use, and 
clinical outcomes. 28-31 
 
IIIC1b.  Theoretical Model Underlying the Development of the Health And Recovery Peer Program (HARP): 
The Health And Recovery Peer (HARP) program was modified from the CDSMP using the Information 
Motivation Behavior Model (IMB).  The IMB, originally developed for understanding HIV, has been extended to 
a variety of settings for understanding use of preventive32,33 and chronic care services.34 This approach is 

 
 
 
increasingly being used as a model both for understanding and improving chronic illness self-management.35, 36   
This model suggested that that while the CDSMP held potential for persons with SMI, it would also require 
adaptation to address the unique issues faced by this population --both group participants and peer educators. 
 
The IMB framework asserts that information, motivation, and behavioral activation are the fundamental 
determinants of successful illness self-management. Information reflects knowledge about the condition that is 
directly relevant to the particular behavior.  Information, however, must be coupled with motivation for behavior 
change. 37, 38  Together, information and motivation make it possible to improve behavioral activation, which 
comprises an individual’s capacity 
to manage his or her own illness 
and work effectively within the 
formal health system. 26, 27, 39 
Behavioral activation is the key 
patient-level precursor to 
improving self-management and 
health seeking behaviors. 
Previous studies in 
general populations have 
suggested a series of moderating 
factors that might be expected to 
identify populations in whom improving self-management may be particularly important.  Social vulnerability 
factors include lack of an adequate support network; medical vulnerability factors represent problems in 
obtaining and maintaining appropriate medical services. 40, 41 Persons in these groups might be expected to 
have more to gain from a program designed to enhance self-management skills.   
 
IIIC1c. Adaptation Process 
With funding from an NIMH intervention development grant, 5R34MH078583, we 
modified the CDSMP for this population using an iterative, theory-driven approach. 42  Initial focus groups were 
followed by a prepilot of the program, and a redrafting of the CDSMP manual in close collaboration and input of 
the developer of the CDSMP and mental health consumers.  The process identified and retained the active 
ingredients of the CDSMP while making needed modifications to allow it to be able to be delivered by, and to, 
mental health consumers.   
  
Modifications to the program were specifically targeted to the deficits in information, motivation, and 
behavioral activation that have been demonstrated for persons with SMI.  Limitations in cognition43 and health 
literacy 44, 45 among persons with SMI might be expected to affect ability to understand and retain information.  
To address these problems, the manual was simplified to a sixth-grade reading level, and a self-management 
record was added to help consumers track disease-specific self-management activities (e.g. measuring blood 
sugar), updated medications, and a list of upcoming appointments, dietary intake, and physical activity.   
Deficits in motivation for persons with SMI may be related in part to limited social networks, and high rates of 
adverse health behaviors within those networks. 46 Thus, each participant was paired with a partner from the 
group, with the two meeting between sessions to work toward accomplishing action plans and goals.   
 
Comorbidity and complexity of conditions may limit these individuals’ behavioral activation both in 
illness self-management,47, 48 and in their capacity to serve as effective patients.49-51  Sections were added to 
the curriculum emphasizing the connection between physical and mental health, and on coordinating 
information between primary care providers and mental health providers.  A section on medical advance 
directives was expanded to include mental health advance directives, which specify preferences if a client is 
unable to make decisions due to psychiatric symptoms.52 Finally, the CDSMP was developed and has largely 
been tested in middle-class populations.  Persons with mental disorders are largely poor and economically 
disadvantaged, making it challenging to afford healthy food or find safe places for physical activity. 53 Thus the 
diet section provided strategies for purchasing healthy food on a budget (including using food stamps) and 
strategies were provided to allow participants to safely exercise in their own homes.  
 
IIIC1d.Randomized Pilot Trial: Subsequently, we conducted a small randomized trial comparing the HARP 
program to usual care for a sample of subjects in the DeKalb County Community Mental Health Center, an 
urban CMHC.1 The purpose of this pilot trial was to establish feasibility, effectiveness, and to inform the 
development of a full-scale randomized trial.  The program was led by two mental health consumers with 
serious mental illnesses and medical comorbidities.  One peer has diagnoses of schizophrenia and congestive 
heart failure; the second has bipolar disorder and diabetes.  
Intervention
HARP
Moderators
Medical/Social 
Vulnerability
Mediators
Motivation
Outcomes
Behavioral Activation
Self Management
Health Outcomes

 
 
 
1. Recruitment and retention: A total of 80 individuals were enrolled in the study.  Among the individuals 
randomized to the intervention (n=41), a total of 33 (80.5%) attended at least one session; 29 (70.7%) 
attended three or more sessions; 26 (63.4%) attended at least 4 sessions, and 22 (53.7%) attended 5 or 6 
sessions. A second pilot using a modified recruitment strategy resulted in considerably higher rates of 
engagement and retention (IIIC1e).  
2. Sample characteristics: The mean age was 48; most (82.5%) were African American, and most were poor 
(mean annual income $7,704 ($2,520, $12,306). The most common mental diagnoses were bipolar disorder 
(32.5%), schizophrenia (28.8%), major depression (26.3%) and PTSD (11.3%).  The most common medical 
comorbidities were hypertension (62.5%), arthritis (48.8%), asthma/COPD (22.5%), and heart disease (22.5%). 
3. 6-month Outcomes:  All outcome analyses were conducted as intent-to-treat, and thus provide a relatively 
conservative estimate of potential intervention effect sizes.  At six month follow-up substantial relative 
improvements in outcome measures were observed for the HARP group relative to usual care, although 
several did not achieve statistical significance due to the small sample size. The table below shows the 
baseline (BL) and six-month measures for the primary outcomes of interest. The table shows the p-value and t-
statistic for the group*time interaction to quantify difference in outcomes over time between the intervention 
versus usual care (UC) groups. We also present the Cohen's d effect size (ES), a standardized measure that 
incorporates both difference in change and variance. 
 
At six month follow-up the HARP group scored higher on the SF-36 Physical Component Summary 
(PCS) than the usual care group. The effect size is larger than those reported in studies implementing the 
CDSMP in general medical populations.54 55 This 3-point relative difference observed in the PCS has been 
found to predict a 15% reduction in inpatient medical hospitalization, and a 20% decrease in 2-year mortality.56  
 
Change in patient activation over time was clinically and statistically significantly higher in the HARP 
intervention than in usual care. As with 
HRQOL, the effect size was larger than 
those seen when the CDSMP was 
implemented in general clinical 
populations.26 Changes of these 
magnitude have been found to predict 
significant reductions in inpatient 
hospitalization, higher rates of diabetes 
and lipid testing, and improvements in 
Hemoglobin A1C control among 
diabetics.57 There was also a significantly 
higher difference in improvement over 
time for the HARP group in the proportion 
of the sample reporting one or more visit to a primary care provider, regarded as a critical element of care 
provision for individuals with chronic conditions.58  HARP participants had an additional 40 minutes per week 
spent in moderate/vigorous exercise compared to usual care.  While not statistically significant, the difference 
in exercise (d=0.19) was nearly identical to the six month effect size for the six month follow-up on the original 
CDSMP study in a general community sample (111 vs. 91 minutes) (Lorig et al. 1999).  The Morisky scale for 
medication adherence has a possible range from zero (no problems) to four (more problems). The mean 
change over time for the HARP group was lower (better) than the mean change for the usual care group 
(d=0.31). 
 
IIIC1e. Open-Label Pilot Study of Modified Recruitment and Retention Strategy: To address the modest initial 
engagement rate in the first study, we tested a modified recruitment approach using a strategy that is being 
used in current dissemination efforts for the CDSMP.59 Participants were recruited at the Fulton County CMHC, 
an urban CMHC, via posted flyers and clinician referrals for an open-label trial to assess subject engagement, 
retention, and fidelity. The same peers who led the initial trial led this series of groups. 
 
The recruitment strategy and eligibility criteria were identical to the strategy proposed for use in the full 
trial which is described in greater detail in IIIC5a.  Potential subjects were invited to attend an initial 
informational session to more fully describe the program and optimize the informed consent process.  
Attendees at this session who were interested in participating and met study eligibility criteria were offered 
informed consent immediately following the informational session.  To optimize retention, peer educators called 
participants 1-2 days prior to each group session as a reminder and to troubleshoot any potential barriers to 
 
Table 1: HARP Pilot Study Outcomes 
 
HARP 
(n=41) 
UC 
(n=39) 
group*time 
P 
T 
ES 
Physical Component 
Summary  of SF-36 
BL 
36.9 
37.0 
.252 
1.16 
.30 
6mos 
42.9 
40.0 
Patient Activation 
BL 
48.3 
47.6 
.030 
2.21 
.56 
6mos 
52.0 
44.9 
>1 Primary 
 Care Visit 
BL 
58.5% 
61.1% 
.046 
2.03 
.51 
6mos 
68.4% 
51.9% 
Medication 
Adherence 
BL 
1.5 
1.5 
.220 
1.24 
.31 
6mos 
1.3 
1.6 

 
 
 
attendance. Aside from bus tokens for those taking public transportation, no financial incentives were provided 
for attending meetings. 
1. Engagement and participation in groups in the second pilot trial was high.  Of 13 individuals attending the 
informational session, 8 were eligible and consented to participate in the pilot. Among those consenting to 
participate (n=8), a total of 4 attended all 6 sessions and the remaining 4 attended 5 out of the 6 sessions, 
resulting in attendance at a mean of 5.5 (SD=0.53) out of 6 possible sessions.  
2. Sample characteristics were similar to the sample for the first pilot study (IIIC1d), and reflective of the clinic 
population (IIIC4) with regards to sociodemographic characteristics (mean age 44; 87.5% African American; 
mean income $5,120), primary mental health diagnoses (37.5% depression; 37.5% schizophrenia; 25% bipolar 
d/o), and medical comorbidities (hypertension 50%; arthritis 37.5%; diabetes 25%; asthma/COPD 25%).  
3. Fidelity was assessed by audiotaping the groups, and using the quantitative fidelity measure described in 
IIIC6e. All audiotapes were rated by the health educator.    Each of the 44 content/activity sections was rated 
using a Likert scale, with 5 being “completely adhered to the written curriculum guide” to 1 being “did not 
adhere to the written curriculum guide at all.”  Totals for two summary categories indicated of 14 out of a 
possible 15 for patient activation enhancing techniques (making an action plan; sharing and feedback; 
modeling and persuasion), and 23.5 out of a possible 25 score on training techniques (lecture with discussion; 
brainstorming; demonstration; feedback; problem solving). 
 
IIIC2. Summary and Rationale for a full trial:  The R34 grant allowed us to develop and manualize HARP.  
Two pilot studies demonstrated potential for high rates of engagement, retention, and fidelity, and promise for 
improving improved key clinical outcomes.  However, these were intended to inform a larger trial and not 
powered to assess statistical significance.  An adequately powered trial is needed to assess whether HARP 
can lead to improved self-management and outcomes.   Second, the pilot study’s outcomes were limited to a 
relatively small number of self-reported measures.  A more diverse set of measures from multiple data sources 
is essential to definitively test HARP’s effectiveness.  Third, the pilot study was conducted in a single urban 
community mental health center, which limits generalizability and the ability to compare impact across different 
types of settings or patient subgroups.  Recruitment from multiple settings will make it possible to establish 
whether the program is effective across a broad population of persons with SMI and also to understand in what 
subpopulations the program works best.  If successful, this study will establish the first evidence-based, fully 
peer-led program to improve physical health and well-being among mental health consumers.  
 
IIIC3.  Overview of the Proposed Research Project:  We propose a multisite, randomized trial of the HARP 
program, an adaptation of the Chronic Disease Self Management Program delivered by, and to, mental health 
consumers. A total of 400 participants will be randomized to either HARP or usual care.  Interviews and chart 
reviews at 3 months, 6 months (primary endpoint), and 1-year after the completion of the groups will assess 
the impact of the program on clinical and functional outcomes and disease self-management skills. 
 
 
IIIC4. Study Setting:  Metro Atlanta CMHCs: The study will recruit from four diverse safety net mental health 
clinics throughout the greater Atlanta region, with two urban and two suburban clinics. The Fulton County 
Department of Health and Wellness is a public health clinic that serves the mental health needs of Fulton 
County, a poor, inner-city County in Atlanta.  The Fulton County CMHC also serves adults with serious mental 
illness in Fulton County.  Two community mental health centers operated by the Georgia Regional Network 
(GRN) provide care within Gwinnett County, a suburban county located 30 minutes north of downtown Atlanta.   
 
IIIC5. Recruitment and Randomization 
Table 2: Characteristics of Study Sites 
Characteristics of Clients 
FY 2009 
Fulton County 
Department of Health 
and Wellness 
Fulton County 
CMHC 
GRN CMHC 
Lawrenceville Clinic 
GRN CMHC 
Norcross Clinic 
# of Adults with SMI served 
4,986 
3,400 
2,029 
921 
Location 
Urban/Inner City 
Urban/Inner City 
Suburban 
Suburban 
Gender   Female 
52.0% 
51.2% 
57.1% 
66.3% 
Race/Ethnicity 
Caucasian 
African American 
Hispanic/Latino 
 
8.7% 
89.9% 
1.0% 
 
20.0% 
77.7% 
2.0% 
 
65.7% 
23.4% 
6.0% 
 
55.1% 
25.9% 
9.5% 
Income below Federal 
Poverty Line 
89.7% 
93.6% 
73.5% 
62.4% 

 
 
 
IIIC5a. Recruitment Strategy: We will recruit and randomize 100 participants sequentially from each site, with 
each site conducting 6 consecutive weekly group meetings of 8-12 participants over a one-year period (1 
group session per week) and then follow-up over a second year.  Rolling recruitment throughout the year will 
be used to minimize waiting time between recruitment and beginning a group program. Based on recruitment 
projections, clients should have to wait no longer than three weeks between recruitment and entry into a group.  
 
To optimize the balance between internal validity and generalizability to community settings, we will use 
the strategy developed for CDSMP dissemination efforts. 59 In our second pilot study (IIIC1e), this approach 
resulted in high rates of engagement, retention, and representativeness of the sample.  Flyers will be posted 
and clinicians encouraged to refer subjects to a one-hour weekly informational meeting scheduled at the 
CMHC.   At this meeting, the project director will provide a one-hour description of the HARP intervention and 
the broader study.  The session will describe the intervention, explain random assignment, review the study 
protocol, detail the informed consent process and confidentiality, and answer any questions.  At the end of this 
session, participants who wish to enroll in the study will provide brief written consent for the screening process, 
then be assessed for eligibility via a review of CMHC administrative records and a brief screening interview.   
 
Inclusion criteria will include: 1. On CMHC roster of active patients.  2. Presence of a serious mental 
illness (schizophrenia, schizoaffective disorder, bipolar disorder, major depression, obsessive-compulsive 
disorder, or post-traumatic stress disorder, with or without comorbid substance use),60 either via CMHC chart 
or the MINI, a brief diagnostic psychiatric interview designed for use in clinical trials. 61 3.  Chronic Medical 
Condition as noted in the CMHC chart or via self-report: (hypertension; arthritis; heart disease; diabetes; and 
asthma/COPD), the most common comorbid conditions seen in the pilot work and other studies in this 
population.62  The exclusion criterion will be cognitive impairment based on a score of > 3 on a 6-item, 
validated screener developed for clinical research. 63   
 
IIIC5b. Randomization:  One fourth of the sample, or 100 individuals, will be randomized at each site.  A block 
randomization strategy will be employed, to ensure balance across each site.  Participants who meet eligibility 
criteria and provide informed consent will be randomly assigned using a computer-generated algorithm and 
concealment of allocation techniques to minimize assignment bias, to either the HARP or usual care.   
 
IIIC6. Intervention: Health and Recovery Peer (HARP) program 
IIIC6a. Overview:  The HARP intervention is a 6-week, 6-session, group format intervention to improve self-
management of chronic medical diseases.  Each group lasts 90 minutes and has 8-12 attendees.  Between 
groups, participants work with partners from the group to troubleshoot problems and accomplish action plans 
identified during the session.  The intervention will be scheduled at a time and location that is convenient to 
participants and does not interfere with work or homemaking activities, typically in the evening.  When feasible, 
meetings will be held in the Wellness Center, a home-like, nonclinical setting run by the Georgia Mental Health 
Consumer Network in downtown Decatur that provides recovery classes as well as a respite program.  Where 
this option is not feasible, classes will be held at the mental health centers.   At the end of the program, 
monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and 
maintain peer support. 
 
IIIC6b. Optimizing Information, Motivation and Behavioral Activation:  
1. Optimizing Information:  Charts and handouts are used throughout the sessions to help convey and 
reinforce key concepts. Each attendee is given a copy of the CDSMP workbook titled “Living a Healthy Life 
With Chronic Conditions” which combines information and interactive exercises for self-management of chronic 
illnesses.64  The book is used as a reference and to reinforce information provided in the groups. Information 
about specific chronic conditions is provided in the form of handouts and through chapters in the CDSMP 
workbook.  Handouts are provided for preventive services, 65 hypertension, 66arthritis,30 diabetes, 67 heart 
disease, 68 and COPD. 69-71 Each participant is provided with a self-management health record that includes 
fields for each of the key targets of the intervention: 1. Disease-specific self-management activities (e.g. 
measuring blood sugar); 2. Updated Medication List 3. List of upcoming appointments 4. Dietary intake and 5. 
Physical Activity.  This is used to track improvement in self-management activities through the study period.  
All materials are targeted to a 6th grade reading level to address limited health literacy. 
2. Optimizing Motivation: Peer support helps improve motivation by solidifying intentions, modeling appropriate 
intensions, and reinforcing positive social norms for self-management, appropriate use of health services, and 
health behaviors. 37, 38  During the first session, each participant is paired with a partner from the group.  
Between sessions, participants are encouraged to meet at least once per week with the partner to accomplish 

 
 
 
a specific action plan outlined during the session.  For instance, the participant and their partner might set a 
plan in which they will shop together for healthy groceries prior to the next session. 
3. Optimizing Behavioral Activation: Each session, clients develop a short term “action plan” related to the topic 
of the session.23  This involves identifying a problem that is of particular concern, listing ideas for solving the 
problem, and then developing a plan outlining specific, short-term goals for improvement.  For instance, the 
plan might be “This week I will walk around the block before lunch on Monday, Wednesday, and Friday for 30 
minutes.” Action plans should be specific and realistic, proposing behavior that the client is confident he or she 
can accomplish.  The client is asked about his or her level of confidence, on a scale of 0-10, that the specific 
goal can be accomplished.  If confidence is 6 or less then goals are modified accordingly and a new action 
plan is developed.  
 
IIIC6c. Individual Sessions (see manual in Appendix for detailed overview of each session):  
1. Session One: introduces the concept of disease self management to attendees. Topics include: 
understanding chronic disease, the basic principles for self management, and an introduction to action 
planning.    At the end of the class, each attendee develops a short-term action plan to help them more actively 
manage their chronic medical illness and obtain appropriate preventive services. 
2. Session Two: provides an overview of problem solving and an introduction to exercise and physical activity. 
The group begins by brainstorming about the potential benefits of exercise and physical activity, with an 
overview of flexibility, strengthening, and aerobic forms of exercise.  This session includes a “hands-on” 
exercise training session including an easy to perform a chair workout covering major muscle groups.  This 
workout includes both strength exercises and some stretching exercises.  
3. Session Three: provides an overview of pain and fatigue management as well as a continuation of the 
exercise program.   Members learn the potential factors causing or exacerbating pain and fatigue, and 
strategies for addressing them, including good diet, exercise, social contact, and relaxation techniques. 
Breathing strategies are developed and the group is instructed in performing progressive muscle relaxation 
techniques.  Participants develop a personal exercise program using the FIT acronym (Frequency, Intensity, 
and Time spent each session) for a successful exercise program.       
4.  Session Four: provides an introduction to healthy eating, including food variety; eating smaller and more, 
regular meals; increasing fruit and vegetable intake; reducing fat and cholesterol intake; reducing carbohydrate 
and salt intake; and increasing water intake.  Sections on reading nutritional labels and weight loss are 
included. A module covers how to shop for healthy, culturally appropriate foods on a limited budget. A “hands 
on” nutrition session consists of a thirty minute cooking demonstration.   
5. Session Five: Peer educators provide an overview of the purposes, benefits, and side effects of common 
medications.  The importance of taking medications as prescribed, even when a patient is asymptomatic, is 
discussed.  A section about combining medications for medical and mental conditions, along with the 
importance of sharing information across different physicians, was added from the CDSMP to HARP.   
6. Session Six:  provides an overview of finding and working with a regular doctor.  Peer leaders present 
strategies for working effectively with a primary care provider, including the following acronym (PART): 1. 
Prepare for the appointment in advance, and bring a list of the most important concerns or questions to the 
visit. 2. Ask about diagnosis, tests, treatments, and follow-up.  3. Repeat back to the provider the key points 
discussed during the visit. 4. Take Action: Let the provider know if there are any potential barriers to following 
through with the recommendations. A final section reviews the highlights from each of the section and asks 
participants to share goals for the coming months.  
 
IIIC6d. Graduation and Alumni Group:  At the final session, participants have a graduation ceremony in which 
they receive a certificate from the program.  This certificate indicates both that they have graduated from the 
HARP program and that they are eligible to participate in a training program to lead groups in HARP. 
Participants are encouraged to continue to meet with the peer partner to set new action plans. An alumni group 
conducted by the peer educators meets monthly for six months after HARP is completed to track progress and 
help participants retain gains made during the program.   
 
IIIC6e: Assessing Fidelity:  Fidelity, or the degree to which the intervention follows the program model,72, 73 will 
be optimized and assessed using standards from the NIH behavior change consortium.74 We have developed 
and pilot tested a fidelity measure (IIIC1e) that will be used in the larger study. 
 
All groups will be audiotaped.  The health educator (Sterling) will review a randomly selected session 
from each group. Sessions will be assessed in terms of overall accuracy and how closely the facilitator 

 
 
 
adhered to the written curriculum guide.  Each of the 44 content/activity sections are rated using a Likert scale, 
with 5 being “completely adhered to the written curriculum guide” to 1 being “did not adhere to the written 
curriculum guide at all.”  These sections are then grouped into two categories: 1. Patient activation enhancing 
techniques, comprising (a) making an action plan (b). sharing and feedback and (c). modeling and persuasion 
and 2. Training techniques, comprising (a). lecture with discussion (b). brainstorming (c). demonstration, (d). 
feedback and (e). problem solving. These are key “active ingredients” of the CDSMP model identified by its 
developers, and have been recommended for use in assessing fidelity of the model. 59, 75 
 
IIIC6f. Selection, Training and Supervision of Peer Leaders: The Georgia Mental Health Consumer Network 
(GMHCN), will identify, hire, and supervise three part-time peer educators who will lead groups across all 4 
sites.  The identical criteria will be used for selecting group leaders as selecting group members; active 
treatment at a CMHC; a serious mental disorder; and a chronic medical condition.  Positions will be advertised 
through postings at the four CMHCs, local newspapers, and listservs.   
 
Peer educators will attend a 4 ½-day workshop at the Stanford Patient Education Research Center.  This 
program is led by the developers of the CDSMP and certifies graduates to lead groups. Each trainee will 
receive a detailed Leader's Manual (see Appendix). After the Stanford training workshop, members of the 
study team, including the Principal Investigator (Druss), Health Educator (Sterling), Diet and Nutrition expert 
(Frediani), Disease Self-Management Expert (Dunbar) Director of the Georgia Mental Health Consumer 
Network (Jenkins-Tucker), and peer-intervention expert (Fricks) will provide a two-day orientation to the peer 
educators including instruction in the HARP manual and study design.  
 
Next, peers will role play two workshop sessions with mock participants, under the supervision of the 
health educator (Sterling) and peer-intervention expert (Fricks).  The health educator and peer-intervention 
expert will provide real-time feedback on all activities.   Sherry Jenkins Tucker, the director of the Georgia 
Mental Health Consumer network, who is a master trainer in the CDSMP, and helped develop the HARP 
curriculum, will attend all six sessions in the first workshop.  She will provide structured feedback to the 
educators after each of these sessions.  If she has any remaining concerns about the peer educators’ ability to 
effectively lead the groups, she will continue to attend these sessions until the concerns have been resolved.   
 
The Georgia Mental Health Consumer network will also provide standardized training to allow the group 
leaders to become certified mental health peer specialists; a standardized 2-week training program focuses on 
teaching skills such as person-centered planning, recovery-based group leadership skills, and Medicaid note 
writing and billing protocols,. The certification process includes both a written and oral test covering these core 
skills.  This will provide added training for the peer educators in leadership and recovery-oriented skills, as well 
as make them eligible to bill Medicaid for services during the dissemination of the intervention. 
 
Subsequently, weekly supervision will be provided to the peer leaders from Ms. Jenkins-Tucker and the 
Principal Investigator.  These sessions will involve reinforcement of core elements of the program, address 
issues and challenges that arise during the sessions, and allow sharing of success stories. 
 
Should peer leaders face difficulties or suffer a relapse, Sherry Jenkins-Tucker and Dr. Druss will work 
with the peer leader to develop a treatment plan with their clinician. One of the other peer leaders will lead 
groups until the consumer is ready to resume leading groups. 
 
IIIC7. Usual Care: Participants in usual care will continue to obtain any mental health or peer-support services 
that they would otherwise be receiving.  While we considered using an active or attention-control comparison 
group, we chose a usual care group, using principles from the NIH consensus panel on the use of usual care in 
study design. 76 Most importantly, that there is no current evidence-based standard of medical disease self-
management that would otherwise be delivered to the control group.77  
 
IIID. Evaluation 
IIID1. Overview: The study will use interview and chart review data to examine the intervention’s impact on 
clinical outcomes, self-management, and quality of medical care at three months, six months, and one year 
after the groups are completed.  As with the CDSMP, 28 six-month analyses will be used as the primary 
timeframe. Three-month assessment will be used to assess shorter term gains after the group sessions and 
one-year assessment will be used to measure the longer-term sustainability of any changes resulting from the 
program.   
 
IIID2. Training, study procedures, and quality control for research interviewers: Research interviewers 
will receive a one-week training program covering the study protocol, interviewing and chart abstraction 

 
 
 
techniques, and ethical issues including privacy protection, and subsequently will receive weekly supervision 
from the Principal Investigator and project director. The project director will oversee three mock interviews to 
ensure that the interviewer has adequately mastered the materials.   
Follow-up interviews and chart reviews will be conducted with the interviewer blinded to participants’ 
randomization status.  Interviewers will be asked to note any instances of “unblinding.”  Sensitivity analyses will 
be conducted including and not including such unblinded information to assess for the possibility of bias.  We 
have used this approach successfully in our other studies.62  
Interviewers will receive training and supervision to ensure close tracking of patients after 
study entry.  In the event that a subject cannot be located at follow-up, a range of search strategies 
will be used including: 1) Social security death index 2) inmate information for local county jails, and 
prisons along with lists of parolees. 3) White pages reverse address look up 4) County property tax 
information and 5) paid internet person-search sites (e.g. Choicepoint). 
 Interview and chart data will be entered in a secured, web-based form with a SQL-based server 
located at Emory University.  A 5% sample of chart reviews will be audited to check on accuracy and 
completeness.  
 
IIID3. Dependent Variables 
IIID3a. Health, Disability and Recovery Outcomes 
1. Physical Health Related Quality of Life (HRQOL): The SF-36 is a measure of HRQOL constructed for use in 
the Medical Outcomes Study. 78, 79 The Physical Component Summary Score is an aggregate measure that 
combines subscales for physical functioning (both actual activities and ability to perform in roles such as work 
and school), bodily pain, and general self-reported health. 80   This will be used as the primary study outcome 
because it is able to capture multiple domains of health and functioning targeted by disease management 
programs, and is predictive of other distal health outcomes including hospitalization and mortality. In other 
populations, the 3-point difference in change found in the pilot study, and targeted in the current study, has 
been associated with a 15% reduction in medical hospitalization, and a 20% increase in 2-year mortality. 56   
 
It is possible that the intervention will have particular benefits for specific domains of physical HRQOL, 
and also that it might have benefits for mental health and functioning. Therefore we will also examine the 
intervention’s impact on each of the four subscales that make up the Physical Component Summary Score, the 
four mental health subscales, and the Mental Component Summary.  
2. Disability: The World Health Organization Disability Assessment Schedule II (WHODAS II) assesses day to 
day functioning in six activity domains. Results provide a profile of functioning across the domains, as well as 
an overall disability score.  81-84 
3. Recovery:  The goals of wellness and health promoted by medical self-management programs are closely 
related to the notion of recovery, the “ability to live a meaningful life …while striving to achieve his or her full 
potential.”  85, 86 To assess whether this chronic disease program also promotes mental health recovery, we will 
use the 41-item Recovery Assessment Scale, a well-tested measure of this construct. 87, 88   
 
IIID3b. Behavioral Activation and Self-Management:  The IMB model suggests that the intervention may 
improve behavioral activation, which will facilitate improved generic and disease-specific self management.  
1. Behavioral Activation will be measured using the Patient Activation Measure (PAM), an instrument which 
has been found to be reliable and valid across a wide range of patient populations.39 As a secondary measure, 
we will also include assess mental health-related behavioral activation using a separate survey, the PAM-MH, 
developed for persons with serious mental disorders. 89  
2. Health behaviors:  Dietary intake will be Kristal Fat and Fiber Behavior (FFB) scale, a validated 20-item 
scale assessing behavior related to low-fat eating, 90-92 and the Block Fat-Sugar-Fruit-Vegetable Screener 
which assesses both frequency and quantity of food intake based on typical eating habits. 93, 94 Physical 
Activity will be assessed with the International Physical Activity Questionnaire (IPAQ), a one-week recall 
measure of physical activity that includes domains for job-related, transportation, housework and family care, 
recreation domains, as well as time spent sitting, 95 and the Paffenbarger questionnaire, which quantifies the 
number of calories people expend per week in sports, leisure, and recreational activities.96,97  
3. Medication Adherence will be assessed using the Morisky scale, a 4-item questionnaire that has been 
shown to have strong content and predictive validity in hypertension,98 cardiovascular disease,99 and 
diabetes.100 Separate indicators will be calculated for each class of medications used to treat hypertension, 
cardiovascular disease, arthritis, asthma, and with an average value across the three cardiometabolic conditions 
used as an aggregate measure of adherence. 

 
 
 
4. Disease-Specific Self-Management Behaviors: This variable will be calculated as the proportion of disease-
specific activities performed for which an individual was eligible. For instance, if a subject has both diabetes 
and hypertension, the variable would be calculated as the sum of the total number of self-management 
activities for both conditions performed by that individual. 101  Established measures will be used for measuring 
arthritis self-management, 102, 103 diabetes self-management, 104 104 hypertension self-management, 105 heart 
disease self-management, 106 and asthma and 107 COPD self-management.108  This approach towards 
aggregating measures is similar to that used for measures of physician-delivered quality of care (see IIID3c). 
 
IIID3c. Quality of Medical Care:  Chronic disease self-management programs have been demonstrated to have 
the potential to improve use of appropriate medical services and decrease use of unnecessary emergency and 
inpatient services.109  A self-reported measure of service use developed for the CATIE trial, the Service 
Utilization and Resources Form (SURF), will be used to track the number of medical and mental emergency 
room visits, outpatient visits, and hospital days. 110, 111 ER admissions for ambulatory-sensitive conditions, 
which can be used as a marker for overuse of medical services, 114-117  will be drawn from the list developed by 
the UCSF-Stanford Evidence-based Practice Center (EPC) for AHRQ. 118  
 
With subject consent, charts will be requested for all sites in which patients received outpatient services. 
In previous studies we have been able to obtain approximately 85% of medical and mental health charts for 
patients in CMHCs.112  Using these charts, quality for the individual study diseases will be measured using 
indicators from the RAND Community Quality Index (CQI) study.101, 113, 114, 115  The quality score for each 
condition is generated by dividing all instances in which recommended care is delivered by the number of times 
a participant is eligible for indicator.  Quality of preventive care will be assessed indicators from the US 
Preventive Services Taskforce Guidelines.65   
 
IIID3d. Moderators, Mediators, and Confounders 
1: Moderator Variables: In general populations, two groups of factors have been found to place populations at 
risk of poor self-management and health outcomes: social vulnerability factors including lack of an adequate 
support network and low SES, and medical vulnerability factors, such as problems in obtaining and maintaining 
appropriate medical services.40, 41  In keeping with those previous definitions, medical vulnerability will be 
defined as lack of a report of a usual source of care, and social vulnerability as report of living alone.  Second, 
we will examine cross-site differences in outcomes, comparing the two clinics in poorer, inner-city 
neighborhoods with those in the middle class, suburban settings.   
2. Mediator Variables: The Information Motivation Behavior Model proposes that information and motivation will 
each be mediators of behavioral activation, which in turn mediates better outcomes. Information  will be 
assessed using a chronic disease knowledge survey that includes questions about diabetes, hypertension, 
heart disease, and asthma,116 and a 15-item arthritis knowledge questionnaire. 117 Motivation will be assessed 
using items from a questionnaire developed and validated in a large community sample which operationalizes 
this construct using the Theory of Planned Behavior. 37, 38  
3. Confounding Variables:  These are variables that are not hypothesized to have a major impact on the 
intervention effect, but which are important to measure to ensure adequacy of randomization and the 
generalizability of the sample.  These will include sociodemographic characteristics:  (age, race, gender), 
medical comorbidity: measured using the Total Illness Burden Index (TIBI),118,119 mental diagnosis using the 
Mini-International Neuropsychiatric Interview (MINI), 61,120  and substance use using the Alcohol and Drug 
Composite Problem Indices from the Addiction Severity Index (ASI).121, 122   
 
Table 3: Summary of Study Measures and Data Collection 
 
Screen  
Baseline 
3-
month 
6-
Month 
1-
year 
Source 
Eligibility Measures 
 
 
 
 
 
 
   Active patient in CMHC 
X 
 
 
 
 
Chart review 
   Serious Mental Illness 
X 
 
 
 
 
Chart review, interview 
   Chronic Medical Condition 
X 
 
 
 
 
Chart review, interview 
   No Cognitive Impairment (Callahan) 
X 
 
 
 
 
Interview 
 Health Outcomes 
 
 
 
 
 
 
   Health Related Quality of Life (SF-36)    
 
X 
X 
X 
X 
Interview 
   Disability (WHODAS) 
 
X 
X 
X 
X 
Interview 
   Recovery (Recovery Assessment Scale) 
 
X 
X 
X 
X 
Interview 
 Behavioral Activation (PAM) 
 
X 
X 
X 
X 
Interview 
 Self-Management 
 
 
 
 
 
 

 
 
 
     Disease-Specific Self-Management 
 
X 
X 
X 
X 
Interview 
     Mental Health Activation (PAM-MH) 
 
 
 
 
 
 
     Diet (Kristal FFB, Block Screener) 
 
X 
X 
X 
X 
Interview 
     Physical Activity (IPAQ, Paffenbarger) 
 
X 
X 
X 
X 
Interview 
     Medication Adherence (Morisky) 
 
X 
X 
X 
X 
Interview 
Quality of Medical Care 
 
 
 
 
 
 
     Disease-Specific Quality Indicators (CQI)   
 
X 
X 
X 
X 
Chart review 
     Quality of Preventive Services (USPTF) 
 
X 
X 
X 
X 
Chart review 
     Ambulatory Sensitive ER/Hospitalizations 
 
X 
X 
X 
X 
Chart Review 
Potential Mediating Variables 
 
 
 
 
 
 
   Information  
 
X 
X 
X 
X 
Interview 
   Motivation 
 
X 
X 
X 
X 
Interview 
Potential Moderating Variables 
 
 
 
 
 
 
   Medical/Social Vulnerability 
 
X 
X 
X 
X 
Interview 
   Study site 
 
X 
 
 
 
Chart Review 
Potential Confounding Variables 
 
 
 
 
 
 
   Sociodemographics  
 
X 
 
 
 
Interview 
   Medical comorbidity (TIBI) 
 
X 
 
 
 
Interview 
   Mental diagnosis (MINI) 
 
X 
 
 
 
Interview 
   Substance Use (ASI) 
 
X 
X 
X 
X 
Interview 
PAM=Patient Activation Measure; FFB=Fat and Fiber Behavior; SURF=Services Utilization and Resources Form; MINI=Mini-
International Neuropsychiatric Interview; WHODAS World Health Organization Disability Assessment Schedule; ASI= Addiction 
Severity Index 
 
IIID4. Data Analytic Strategy 
IIID4a. Overall analytic strategy:  All analyses will be conducted as intent-to-treat.  Six-month outcomes will be 
the primary study endpoints, consistent with previous work using the CDSMP.  3-month outcomes will be used 
to examine short-term intervention impact and 1-year endpoints will assess the longer-term impact of HARP. 
The primary analytic technique for assessing differences between the study groups will be random regression 
(repeated measures GLM), 123 comparing the difference in change between groups over time. Analyses will 
adjust for site as a random effect, given the goal to generalize to other clinics.  These will be conducted using 
the SAS MIXED procedure for continuous variables and PROC GLIMMIX, which is the preferred procedure for 
binary and ordinal variables when there are relatively few observations per subject.124 
 
IIID4b. Departures from Randomization, Noncompliance, and Loss to Follow-Up: 
1. Baseline departures from randomization: Potential confounding variables that differ significantly between the 
groups at baseline will be included as covariates in subsequent analytic models.  
2.  Noncompliance/Dropout from Treatment:  Although the primary analyses will be conducted as intention-to-
treat, we will also conduct a series of analyses to model incomplete group attendance.  Partial attendance will 
be modeled using method-of-moments estimators, which are extensions of econometric instrumental variables 
techniques.125, 126 This procedure accounts for compliance status and correlation between compliance status 
and nonresponse.  Treatment assignment  is used as an instrument, and analyses are conducted to estimate 
causal effects.127  Dr. Peng has experience in using this methodology. 
3. Loss to Study Follow-Up/Missing Data: In addition to the strategies described in section IIID2 for optimizing 
study retention, appropriate analytic techniques will be used to adjust for loss to follow-up. Multiple imputation 
techniques128,129 will be used as the initial strategy for handling missing data.  In the case that there is evidence 
that these data do not satisfy the missing-at-random assumption, they will be supplemented with selection 
models and pattern-mixture models that relax this assumption.128,130,131  
 
IIID4c. Hypotheses and Methods for Each of the Specific Aims  
H1. As compared with participants referred to usual care, participants in HARP will have greater improvement 
in physical health-related quality of life, disability, and recovery-based outcomes. The Physical Component 
Summary (PCS) is scored between 0 (poor health) to 100 (perfect health).  The oblique method, which is the 
preferred approach when examining persons with comorbid physical and mental conditions, 133, 134 will be used 
to calculate summary scores.135 Other subscales of the SF-36, the WHODAS, and the Recovery Assessment 
Scale are also scored as continuous outcomes. Random regression analyses will examine the group*time 
interaction term for each of these continuous variables to assess statistical significance, adjusted means, and 
confidence intervals.  

 
 
 
H2. As compared with participants referred to usual care, participants in HARP will show greater improvement 
on validated measures of behavioral activation, and generic and disease-specific self-management and quality 
of medical care.  Patient activation, aggregate disease management, medication compliance, and quality of 
care are scored as continuous measures; random regression analyses will examine the group*time interaction 
term for each of these variables to assess statistical significance, adjusted means, and confidence intervals.     
H3. Medical or social vulnerability will be associated with greater improvements from HARP in health related 
quality of life:  Moderator analyses make it possible to identify what types of clients benefit most from a given 
intervention.  The approach will follow Kenny et al’s method for analyzing moderator effects in randomized 
trials using random regression. 136 For each moderator of interest we will use the models in H1 and H2 with a 
group*time*moderator interaction term, the statistical significance of which will allow us to assess the presence 
of moderation. All appropriate lower-order interactions will also be included in the model.   
H4. Information and motivation will each mediate the impact of the intervention on patient activation.  Patient 
activation, will, in turn, mediate the impact of the intervention on health related quality of life  Mediation 
analyses will use adaptations of structural mean models developed by Ten Have. 137, 138 Models will be 
constructed to examine the relationship between the independent variable (study arm), the outcome (either 
patient activation or health related quality of life) and each putative mediator (information, motivation or patient 
activation). Models will determine whether 1. Intervention status is associated with the hypothesized outcome 
at six months. 2. Intervention status is associated with the hypothesized mediator at three months. 3. Adding 
the hypothesized mediator at three months in a multivariate model significantly reduces the magnitude of the 
association between intervention status and the outcome variable.  All models will include covariates that are 
significantly correlated with randomization status, mediating variables, or outcomes at baseline. The Sobel 
Test, as specified by MacKinnon and Dwyer, 139 will be used to test the statistical significance of the separate 
impact of each hypothesized mediator on the direct effect of the baseline intervention by comparing adjusted 
and unadjusted effects of the intervention relative to their standard errors.  
 
IIID4d. Sample Size Calculation:  Sample size calculations were conducted using the Power Analysis 
Statistical Software (PASS). Our goal is to have 80% power to detect a statistically significant difference in the 
change in outcome over time between the intervention and usual care groups. We assume alpha=.05, two-
tailed tests, and a 20% attrition rate over the follow-up period. A final sample of 320 (160 in each treatment 
arm) will provide 80% power to detect the group*time interaction for the primary study outcome, and for other 
effect sizes of Cohen's d=0.30. 
1.Physical Component Summary Score of the SF-36 (Primary Study Outcome):  A final sample of 320 (160 in 
each treatment arm) will provide 80% power to detect a statistically significant group*time interaction for the 
effect size seen in the pilot study (Cohen's d=0.30). This equates with an improvement of 3 points on the PCS 
and is regarded by the developers of the survey as the threshold for a clinically significant effect size.56  
2. Other Study Outcomes: 1. For patient activation, a sample size of 320 will provide an adequate power to 
detect a 3-point differential change, found to be associated with significant beneficial changes in screening 
behaviors and health outcomes.57  2. For medication adherence, we anticipate having adequate power to 
detect a 0.3 difference (Cohen’s d of 0.3).  3. For the quality of medical care and quality of self-management 
we anticipate having 80% power to detect a 10% relative change difference. 112  
3. Mediator analyses: Using methods developed by Fritz and MacKinnon,140  a final sample of 320 will provide 
80% power to detect a significant mediation effect if there is a moderate effect size in the relationship between 
the intervention and the outcome (e.g. health related quality of life) and a small (t’=.11) remaining direct effect 
after controlling for patient activation (i.e. partial mediation). This sample size is sufficient to detect the 
mediated relationship when the association between the intervention and the mediator, and the mediator and 
outcome are both in the small to moderate range (r2 =0.14-0.26). 
4. Moderator analyses: According to Kenny the estimate of the moderator effects can be viewed as a 
comparison of Cohen's d across levels of the moderator.141 This difference is itself a Cohen's d. Our final 
sample size of 320 will provide power of 80% to detect a moderate effect, or a difference in Cohen's d of d=.3 
between levels of the moderator (i.e. d=.2 for group*time on the outcome in the high medical vulnerability 
group and d=.5 for group*time on the outcome in the low medical vulnerability group).  
 
IV. Dissemination Phase: The final year of the study will be spent on piloting a dissemination strategy that 
would build on the approach and infrastructure used in the CDSMP. The CDSMP approach is built on a 
pyramidal workforce approach in which peer educators can become certified as “master trainers,” who train 
other peers as group leaders.  This strategy has made it possible to disseminate the CDSMP to 510 different 

 
 
 
sites in every state of the US and 32 countries across the globe. 59  Because HARP has been designated as an 
official derivative of the CDSMP, it will be possible to build on the broader CDSMP infrastructure for these 
dissemination efforts.    
During the final year of the project, the three peers who have been administering the intervention will 
become master trainers through the Stanford CDSMP training program as well as supplemental instruction 
through the HARP team.  The Stanford master training program includes instruction in identifying appropriate 
peer leaders, core programmatic elements, and maintaining program fidelity. It provides training, direct 
observation, and feedback on the process of teaching peer educators how to lead groups.  This program will 
be followed by a three-day inservice training program led by the principal investigator and Sherry Jenkins-
Tucker, which will focus specifically on helping these new master trainers develop skills to instruct other mental 
consumer peer educators. 
Three subjects who participated in the intervention program will be recontacted by these new master 
trainers and invited to become peer educators in the dissemination phase.  Peers will keep a log of number of 
groups led and number of members attending each group; sessions will be audiotaped.  Data will be collected 
on engagement, retention, and fidelity to the HARP protocol.  Peers will bill for these services through Medicaid 
or the Department of Mental Health for uninsured clients. Coupled with the effectiveness data from the current 
study, information on this dissemination pilot will help establish the feasibility of a larger strategy to disseminate 
HARP broadly within a group mental health peers.   
 
V. Potential Limitations: While we believe the proposed study has a number of strengths, including building 
on an evidence-based self-management approach, and the potential for sustainability and generalizability, we 
also recognize several limitations:  1. Diversity of chronic conditions and health behaviors:  The proposed 
program, like the CDSMP, will treat patients with a variety of medical conditions.  We recognize that this may 
reduce the ability to track specific disease-based outcomes.  However, this strategy may increase 
generalizability to public mental health settings.  If successful, this may increase the program’s reach and 
adoption more broadly. 2. Focus on Self-Management Rather than Provider or System-Based Approaches:  
Approaches such as the Chronic Care Model primarily focus on change at the provider/practice level as a 
strategy for improving illness outcomes.142   In contrast, the CDSMP and HARP programs focus on improving 
the determinants of health outcomes that are under a patient’s control, including those that occur outside of the 
formal health system. This latter approach is particularly applicable to programs implemented in community 
settings and within the peer workforce.  These two types of approaches are each critical, and potentially 
complementary strategies for addressing morbidity and mortality in mental health consumers. 3. Challenges in 
implementing the program as a fully consumer-based approach:  We recognize that having the HARP groups 
led by mental health consumers is more logistically complex than if groups were led by professional staff such 
as nurses or dieticians. However, our initial work suggests that this approach is not only feasible, but extremely 
empowering for participants, and may provide unique benefits in improving activation and self-management.   
 
VI. Timeline: We anticipate that approximately 6 months will be required to hire and train research and peers 
prior to starting recruitment.  The intervention will be sequentially implemented at each of the four study 
locations. At a rate of 13 participants per month (derived from our experience on the pilot study), recruitment is 
anticipated to last 30 months, with the interview data complete approximately one-year afterwards. 
Dissemination activities will occur during the final year of the study.  
 
 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Hire and Train Staff  
  
 
 
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
Recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
VII. HUMAN SUBJECTS 
This study tests a randomized trial of a medical disease self-management program for mental health 
consumers.  A total of 400 individuals with serious mental illnesses and one or more chronic medical condition 
(hypertension; heart disease; arthritis; diabetes; or asthma/COPD) will be recruited at four community mental 
health centers and randomized to HARP or usual care.  For individuals in HARP, peer leaders will lead six 
group sessions focusing on improving medical self-management.  Outcome data will be collected at 3-months, 
6-months and 12-month intervals after the group program is completed.   
 
VIIA. Protection of Human Subjects 
VIIA1. Sources of research material:  
VIIA1a. Interviews:  Interviews will be conducted at baseline, 3 months, and 12 months after the completion of 
the intervention. Interviews will be conducted in private rooms where peer groups are led.   
 
VIIA1b. Chart Reviews:  After initial consent, CMHC charts and interview will be used for establishing study 
eligibility.  For study participants, medical charts will be obtained for all mental health and medical visits for all 
study participants.  These will be reviewed at baseline and 12-month follow-up, with data entered into a 
standardized abstraction form.   
 
VIIA2. Plans for Recruitment of Subjects:  Recruitment for the groups will rotate across the four study sites, 
with separate sets of groups for subjects at each CMHC.  At each study site, weekly one-hour informational 
sessions will be held at the CMHC.   Participants will be notified about these sessions via clinician referrals and 
waiting room flyers. At these sessions, the project director will outline the overall purpose of the study, and the 
fact that if they choose to participate they will be assigned randomly to either the intervention or control group. 
The project director will describe the group format and content of the intervention, as well as the importance of 
being able to attend the full program to achieve its benefits.  Among those interested in participating, subjects 
will be offered informed consent to participate in the study by the research interviewer on a one-to-one basis.  
 
VIIB. Informed Consent:  
 
A two-stage informed consent process will be used for the randomized trial and the dissemination phase 
of the study.  First, brief written consent will be obtained to participate in the eligibility process, which includes 
checking the CMHC records for assessing that the subject is on the roster of established patients, and 
establishing presence of mental (SMI) and medical diagnosis.  Potential subjects will be administered a 
cognitive screener.  Next, after eligibility has been established, study participants will be given a full written 
informed consent for the research study.  The senior research interviewer will review the content of the 
informed consent and emphasize that the study is voluntary and confidential.  The senior research interviewer 
will then ask the study participant to briefly describe what the study is about to establish understanding, and 
ask if she has any questions prior to asking the study participant to sign the informed consent form. 
 
Informed consent will only occur if and only if a subject with substantial understanding and in absence of 
control by others. The research staff will be trained to ensure that the individual is competent to act, receives 
full disclosure, understands the disclosure, acts voluntarily and consents to the intervention.  If there are 
questions with regards to the individual's competence, the research interviewers will contact the PI for 
guidance. 
 
The informed consent process for the randomized study will include the following: notification that 
participants will be interviewed four times (baseline, three-month, six-month, and 1-year follow-up); that half of 
participants (selected at random) will participate in a medical disease self-management program; that groups 
may be audiotaped; that agreement to participate in the study does not obligate participants to accept any 
particular treatments; and that participants are free to withdraw from any part of the study (either the 
intervention program or the follow-up assessments) at any time.  After study entry, a separate informed 
consent form will be administered to obtain permission to obtain chart records.  For the dissemination pilot, the 
informed consent will contain information about the program, but not include the sections about randomization, 
interviews, or chart reviews. 
 
VIIC. Potential Risks  
VIIC1.  Acute medical or mental health crisis: It is possible that patients will be found to be in a medical or 
mental health crisis at the time of screening or that a new problem will emerge sometime during the study. The 

 
 
 
exercise class is both extremely low-impact and designed for use in chronically ill populations.  However, it is 
possible that that it could induce discomfort or medical complications.  It is also possible that the peer leaders 
may have a relapse or face other challenges during the study.  Mechanisms for addressing these risks are 
described below in section VIID3a. 
 
VIIC2.  Incorrect Medical Information or Advice Given to Participants by Peers:  Although no formal 
medical treatment or medical advice will be provided in the study, it is possible that either peer leaders or 
fellow group members would give incorrect information to group members.  Mechanisms for addressing that 
potential concern are described in section VIID3b. 
 
VIIC3. Breach of confidentiality: It is essential to monitor and minimize the possibility that the research staff, 
peer leaders, or other group members might reveal personal or sensitive patient information to medical 
providers or family members. Section VIID1 describes the training and supervision process and VIID3c 
discusses methods for keeping such breaches from occurring in either the focus group or the randomized trial.  
 
VIIC4. Subject Burden: Study assessments will always result in an expenditure of time and inconvenience for 
subjects, as well as the potential for discomfort or embarrassment related to the content of the interview.  
Section VIID3d discusses mechanisms for minimizing subject burden. 
 
VIID. Adequacy of Protection against Risks:  
VIID1. Hiring, Training and supervision of peer leaders  
 
Group leaders will be selected using the same inclusion criteria as group members:  1. History of SMI60 2. 
Current treatment in a community mental health center and 3. one or more chronic medical condition.  The 
Georgia Mental Health Consumer Network, which oversees the training and certification program, will then hire 
and supervise three part-time peer educators who will lead groups across all 4 sites.  
 
 Peer educators will attend a 4 ½-day workshop at the Stanford Patient Education Research Center.  
After the Stanford training workshop, members of the study team will provide a two-day orientation and training 
program.  The GMHCN will provide additional training in recovery-based treatments and help peers obtain 
certification and allow them to bill for services.  Subsequently, weekly supervision will be provided by the 
principal investigator and Sherry Jenkins Tucker, the director of the GMHCN, to the peer leaders reinforcing 
core elements of the program, address issues and challenges that arise during the sessions, and allowing 
sharing of success stories. 
 
For the dissemination phase of the study, group participants will be invited to train as peer leaders. They 
will receive training from the CDSMP program, the GMHCN (Sherry Jenkins-Tucker) and the former peer 
educators (who will have been retrained as master trainers). 
 
VIID2. Training and supervision of the research assistants:  
 
The Principal Investigator  will organize a training program including a) an overview of research and 
ethical issues involved in randomized clinical trials; b) administration of informed consent and c) patient 
confidentiality (with a focus on recent HIPAA regulations).  Classes will be supplemented with the NIH Human 
Subjects Assurance training and self-test program.   The project manager will provide training in chart 
abstraction and administration of each of the structured interviews, accompanied by reference manuals.    The 
project manager will provide basic training in data entry, data backup, and maintaining patient confidentiality in 
all entry and storage of data.  
 
The principal investigator and/or project manager will observe the first three instances of each activity 
conducted by the research assistants: screening interviews and informed consent processes, interviews, and 
chart reviews.  If there are continuing issues at the end of this period, they will continue to observe and provide 
oversight until they are resolved.  Subsequently, weekly supervision meetings will be held with the research 
assistants, presenting statistics on rates of recruitment, follow-up, and any problems that arise, with periodic in-
service lectures about topics such as confidentiality. 
 
VIID3. Protection Against Specific Risks: 
VIID3a. Protocol for addressing acute medical or mental health crisis: 
 
In the case that a subject describes any potentially serious symptoms (e.g. chest pain, shortness of 
breath) in either a group or a study interview, the research assistant or peer leader will immediately contact the 
principal investigator or project manager. Based on the clinical situation, acuity, and patient preferences, a 

 
 
 
decision will be made whether to a. Contact the patient’s primary care provider or mental health clinician or b. 
Call 911 for immediate assistance.   
 
The study subjects are not directly asked about suicidal ideation. However, should subjects raise this 
concern to one of the research assistants or in a peer group, they will ask the patient to remain onsite after the 
interview and immediately call Dr. Druss who will establish a plan for follow-up.  The plan will typically involve 
an urgent referral to the client’s mental health clinician for further assessment and care, and obtaining consent 
for the study investigator to speak with that clinician.    
 
VIID3b. Addressing possible relapse of peer leaders: 
 
The peer educators will be closely supervised throughout the study by Dr. Druss and Sherry-Jenkins 
Tucker, who is the Director of the Georgia Mental Health Consumer Network and the Principal Investigator.  
Should peer leaders face difficulties or suffer a relapse, Sherry Jenkins-Tucker and Dr. Druss will work with the 
peer leader to develop a treatment plan with their clinician. One of the other peer leaders will lead groups until 
the peer is ready to resume work. 
 
VIID3c. Minimizing Risk of Incorrect Medical Information or Advice Given to Participants by Peers:  Within the 
HARP group settings, all information and activities will be given in a highly structured, manualized format.   For 
both these group settings and any contacts with peer leaders or fellow group members outside of the classes, 
it will be made clear to all participants and group leaders that they that the role of this program is to provide 
support in disease self-management, but in no way to substitute for clinical care.  Should subjects have 
medical symptoms or questions, they will be encouraged to contact their primary care physicians, since neither 
peer leaders nor fellow participants are not qualified to provide formal medical advice.  This will be specified to 
all subjects as part of the informed consent process, and in training and supervision of the peer leaders. 
 
VIID3d. Protecting against breach of confidentiality:  
VIID3di.  Protecting against breach of confidentiality by peer leaders or other group members: All peer leaders 
will be trained in protection of confidentiality.  Each session will begin with a statement that whatever is said 
during the group session is confidential and not to be discussed outside of the group. Similar instructions will 
be included for all focus groups. 
 
VIID3dii. Preserving privacy and integrity of data: A web-based, password-protected SQL database will be 
created and housed on a protected drive on the Emory server.  Data will be directly entered into this central 
database during data collection.  Unique identifiers will be generated for all study subjects; these will be the 
only identifiers used in files used for data entry and analysis.  The file linking these identifiers to patient names 
and addresses will be stored in a separate locked file that will be available only to the principal investigator and 
project manager.  
 
VIID3e. Minimizing subject burden:  
 
Interviews will be scheduled at a time and location that is as convenient as possible for patients – when 
possible, prior to or directly after a mental health appointment.  Interviews will be conducted in a private, 
comfortable setting.  If a subject appears tired or anxious, the subject will be asked if he or she wishes to rest, 
take a break, or terminate the interview.  Subjects will be paid $20 for each interview to help compensate for 
time and effort.  
 
The intervention will be scheduled at a time and location that is convenient to participants and does not 
interfere with work or homemaking activities, typically in the evening.  When feasible, group meetings and 
interviews will be held in the Wellness Center, a home-like, nonclinical setting run by the Georgia Mental 
Health Consumer network in downtown Decatur that provides recovery classes as well as a respite program.  
Where this option is not feasible, classes will be held at the mental health center where patients receive their 
care.  Bus and/or subway tokens will be provided to facilitate transportation to the meetings, and refreshments 
will be provided. 
 
 
VIIE. Potential Benefits of the Proposed Research Project to the Subjects and Others: 
VIIE1. For subjects in the usual care group: During the study period the usual care group will not receive 
any benefits from the program other than compensation for time completing interviews. After the initial study 
period and during the dissemination phase, they may have the opportunity to participate in the intervention.  
VIIE2. For subjects in the intervention group: Subjects participating in the intervention group are expected 

 
 
 
to directly benefit from the intervention.  As described in the body of the proposal, we anticipate that the 
intervention may improve medical self-management and health outcomes. 
VIIE3. For other persons treated in public safety net settings: The study’s results are hoped to inform the 
development of peer-based medical disease management strategies.  Strategies described in section V will be 
used to disseminate the results of the study to help obtain the broadest possible reach. 
VIIE4. Risk-Benefit Ratio:  Given the protections to ensure confidentiality, ensure high quality of the 
intervention, and minimize subject burden, and the benefits for patients in the active treatment group, we 
anticipate a favorable risk-benefit ratio for the project. 
 
VIIF. Data Safety and Monitoring Plan:  
VIIF1. Responsibility, Frequency, and Content of Data Safety Monitoring: The Principal Investigator will 
be involved in all aspects of the research and will be responsible for monitoring all data.  The PI will review 
safety data on a monthly basis during the course of the study.  
VIIF2. Adverse Event Reporting: Adverse events data will come from two sources: 1) Patient reports to study 
staff and 2) Chart reviews.   Any deaths will be reported upon discovery to the IRB.  All other study-related 
serious adverse events will be reported immediately to the Emory IRB. 
 
VIIG: Women and Minority Inclusion 
 
 
TARGETED/PLANNED ENROLLMENT FOR RANDOMIZED TRIAL: Number of Subjects 
 
 
Ethnic Category 
 
 
                  Sex/Gender 
Females 
Males 
Total 
Hispanic or Latino 
5 
5 
10 
Not Hispanic or Latino 
201 
189 
390 
Ethnic Category Total of all Subjects 
206 
194 
400 
 
Racial Categories 
American Indian/Alaska Native 
0 
0 
0 
Asian 
3 
2 
5 
Native Hawaiian or Other Pacific Islander 
0 
0 
0 
Black or African American 
163 
153 
316 
Hispanic or Latino 
5 
5 
10 
White 
35 
34 
69 
Other 
0 
0 
0 
Racial Categories: Total of All Subjects 
206 
194 
400 
 
VIIG1. Inclusion of Women Women will be included in the enrollment process and we expect them to be 
well-represented based on the characteristics of the CMHCs from which they are recruited.   
 
VIIG2. Inclusion of Minorities Minority groups are well-represented in the mental health centers, and will be 
included based on their representation in that population.   
 
 
  
VIIG3. Inclusion of Children 
 
 
Because children under age 18 have different health problems and needs from adults, they would not 
easily be integrated into the broader intervention, and hence will not be included in intervention.  Approximately 
5% of patients at the four CMHCs are between the ages of 18 and 20, and thus are considered children under 
NIH guidelines. The CDSMP intervention and study instruments have been validated in the age group (i.e. age 

 
 
 
18 and older).  Therefore, individuals age 18-20 will be included in the study, and there is no reason to expect 
that special accommodations will be needed for the group.   
 
 

 
 
 
 
 
 
 
 
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