Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: Vanderbilt University Medical Center

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
 
 
 
 
 
 
 
 
Mobile Phone Support for Adults and Support 
Persons to Live Well with Diabetes 
  
FAMS 2.0 RCT 
 
 
PI: Lindsay Mayberry, PhD, MS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
 
 
 
 
Table of Contents: 
 
FAMS 2.0 RCT 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems Involving Risk 
to Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 Follow-up and Record Retention 
 
 
FAMS 2.0 RCT Secondary Analyses: Expansion of Aims 
11.0 Background 
12.0 Rationale and Specific Aims 
13.0 Study Procedures 
14.0 Statistical Considerations 
 
 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
1.0 
Background 
 
For adults with type 2 diabetes (T2D) performing recommended self-care improves 
glycemic management (hemoglobin A1c) and prevents disease-related complications 
and premature mortality. Achieving good self-care remains very challenging, and there 
may be significant benefits to involving close family and friends in patients' behavior 
change efforts. Family members and friends can either reinforce or undermine patients' 
self-care, and many experience distress about not knowing how to best support the 
patient's self-care efforts. Both in-home and out-of-home support directly affect patients' 
self-care, medication adherence, and glycemic control. Moreover, family/friend support 
indirectly affects diabetes outcomes through its benefits to diabetes distress and quality 
of life. The large international Diabetes Attitudes, Wishes, and Needs follow-up study 
(DAWN2) found that although patients' family members clearly want to help them, they 
lack basic knowledge about how to do this effectively. Additionally, many family 
members experience significant distress and other negative impacts themselves. 
Although engaging family/friend support persons may be a highly effective way to 
improve outcomes for adults with T2D and their support persons, this has rarely been 
investigated. There is a critical need for feasible interventions for adults with T2D to 
enhance supportive social environments for health behavior change and improve 
psychosocial wellness among patients and their support persons. 
 
We developed a mobile phone-delivered diabetes self-care support intervention called 
FAMS (Family/friends Activation to Motivate Self-care) with and for racially diverse adults 
with T2D receiving care at Federally Qualified Health Centers. FAMS includes phone 
coaching for patient participants focused on improving family and friend involvement 
and setting and monitoring self-care goals. FAMS also includes text message support for 
patient participants and text message support for their adult support person. FAMS uses 
one-way informational text messages and interactive text messages, and patients’ and 
support persons’ text messages are tailored to the self-care goals patient participants set 
during monthly coaching. We completed usability testing and integrated users’ feedback 
before we evaluated FAMS in a pilot RCT. In the pilot RCT, FAMS established its 
acceptability and accurate delivery and demonstrated improvements in family/friend 
involvement in patients' self-care, and in patients' diabetes self-efficacy, eating behavior, 
and physical activity. 
  
2.0 
Rationale and Specific Aims 
 
We built upon these promising initial findings by expanding and improving FAMS 
through usability testing and before evaluating FAMS 2.0 in a larger, 15-month 
randomized control trial (RCT) including support persons (SPs) in both the intervention 
and control condition. This project's focus aligns closely with the American Diabetes 
Association's new psychosocial standards and represents an advance in the use of 
technology to deliver patient and family-centered care. Moreover, this work has the 
potential to improve the social contexts in which adults live with T2D, key diabetes-
related psychosocial outcomes for patients and their family/friends, and glycemic 
management. 
 
 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
 
The aims of this RCT are: 
1. Among patient participants, to evaluate the effects of the expanded FAMS 2.0 
intervention versus enhanced treatment as usual (print materials on T2D self-
care and access to A1c results) on glycemic management (A1c; primary 
outcome) and psychosocial well-being (diabetes distress and global well-
being; secondary outcomes). We examine effects during the 9-month 
intervention period and sustained effects after the intervention periods ends. 
2. Among support person participants, to explore effects of the expanded FAMS 
2.0 intervention versus enhanced treatment as usual (print materials) on 
psychosocial well-being (diabetes distress) and support burden. 
3. To examine intervention effects on intervention targets including: 
a. Patient participants: family/friend helpful involvement, family/friend 
harmful involvement, diabetes self-efficacy, and diabetes self-care 
behaviors 
b. Support person participants: support person’s own involvement in the 
self-management of the person with diabetes 
4. To test hypothesized mediators and explore subgroups difference of 
intervention effects. 
 
3.0 
Inclusion/Exclusion Criteria 
 
Patient participants: 
Inclusion 
• 
Speaks and reads in English 
• 
18-75 years old* 
• 
Diagnosed with type 2 diabetes* 
• 
Receiving outpatient care from a partnering clinic* 
• 
Community-dwelling (e.g., not in a nursing facility) 
• 
Prescribed at least one daily diabetes medication 
• 
Owns a mobile phone 
 
Exclusion 
• 
Unable to communicate by phone 
• 
Currently pregnant  
• 
Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)* 
• 
Diagnosed with end-stage renal disease* 
• 
Had a discharge disposition for hospice* 
• 
Diagnosed with congestive heart failure* 
• 
Diagnosed with dementia* 
• 
Diagnosed with schizophrenia* 
• 
Reported current abuse during screening 
• 
Demonstrated an inability to receive and respond to a text 
• 
Did not take medication on his/her own/medication administered by someone 
else 
 
NOTE: * indicates patient eligibility criteria identified with electronic medical record data 
via a validated phenotype algorithm 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
 
Support persons: 
Inclusion 
• 
Speaks and reads in English 
• 
18 years or older 
• 
Owns a mobile phone 
 
Exclusion 
• 
Demonstrated inability to receive & respond to a text 
 
4.0 
Enrollment/Randomization 
 
Potentially eligible participants were identified through a clinical data warehouse that 
queried electronic medical records (EMR). We mailed letters and a study brochure to 
potentially eligible participants, asking that they let research staff know of their interest 
or to request no further contact. After one week, study staff called potential participants 
who did not opt-out to explain the study and assess interest. Interested participants 
confirmed inclusion and exclusion via self-report by phone and then completed informed 
consent by phone. Enrolling participants were asked if they wish to invite a support 
person, but support person invitation and/or enrollment was not required. Research staff 
obtained contact information for a potential support person. Research staff then 
contacted potential support persons to confirm eligibility and obtain their verbal 
informed consent by phone. All participants were sent a copy of the consent document. 
 
Consented patient participants were sent a survey and A1c kit and consented support 
person participants were sent a survey. Once patient participants completed the survey 
and put their A1c kit in the mail, they were randomized. Support persons were 
randomized with the patient participant.  
 
Participants (or dyads) were randomized to intervention or control with a 1:1 ratio. As 
baseline data were available at randomization, the study statistician performed an 
adaptively stratified randomization process to ensure balance between treatment arms 
on support person enrollment status and baseline values of outcomes of interest for the 
patient participant. The randomization algorithm placed relative importance on balancing 
specific covariates through weighting, the balance of which shifted once during 
enrollment in response to an imbalance in baseline variables. The statistician gave study 
staff randomization assignments after participant enrollment and baseline data collection 
were complete, blinding allocation until randomization.  
 
Then, study staff contacted participants to tell them what to expect during their 
participation. This includes an overview of study components specific to their assigned 
condition and collection of mobile phone information and preferences for the text 
messaging platform. 
 
 
 
 
 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
 
5.0 
Study Procedures 
 
Procedure/Activity 
Frequency 
Survey (patient participants and SPs) 
Baseline, 6mo, 9mo, 15mo 
A1c test (patient participants) 
Baseline, 6mo, 9mo, 12mo, 15mo 
Diabetes educational materials (patient 
participants and SPs) 
Baseline and quarterly (4x per year) 
FAMS 2.0 mobile phone intervention 
(patient participants) 
Approx. 2 texts per day for 9 months 
FAMS 2.0 mobile phone intervention (SPs) 
Approx. 4-5 texts per week for 9 months 
FAMS 2.0 phone coaching (patient 
participants) 
Approx. 25-30 min. calls once a month for 
nine months 
 
All data were stored in REDCap. Information collected as part of regular care was 
collected from patient participants’ EMR (e.g., birthdate, gender, A1c test results, height, 
weight, BMI, medications, co-morbidities, etc.). Surveys were administered to all 
participants at baseline, 6, 9, and 15 months—online, mailed copy, or by telephone. A1c 
results were collected from persons with diabetes with each survey as well as at 12 
months. Participants received mail-in HbA1c test kits provided by CoreMedica 
Laboratories. HbA1c values collected as part of clinical care were also extracted from the 
EMR.    
 
Patient participants assigned to control group:  
Text messages - Patient participants received a text message when their A1c result was 
ready (baseline, 6mo, 9mo, 12mo, 15mo). 
 
Patient/SP dyads assigned to FAMS intervention:  
Phone coaching - Patient participants completed a phone coaching session with a 
trained coach once a month for nine months (10 total sessions; 9 core sessions and a 
brief 10th wrap-up session). Coaching sessions lasted 25-30 minutes each. Coaching 
sessions included: 
• 
Setting a behavioral goal that can be completed at least 4 days per week in the 
categories of dietary behavior, physical activity, or stress management (setting 
and/or adjusting the goal, check in on goal progress) 
• 
Skill building around family/friend involvement in diabetes management, specific 
to the goal (discussion of helpful and/or harmful family involvement, coach-
selected skill building to align with and address the patient participant’s 
experiences, setting a verbal contract to practice the learnt skill with a specific 
identified person and – at subsequent sessions – check in on how that went). 
 
 
 
 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
Text messages - Patient participants received a text message when their A1c result was 
ready (Baseline, 6mo, 9mo, 12mo, 15mo). They also received approximately 2 texts per 
day for 9 months: 
• 
3 to 4 one-way texts per week pertaining to goal set in the patient participant’s 
most recent coaching session; sent randomly within a window of time identified 
as convenient by the patient participant 
• 
3 to 4 one-way texts per week pertaining to medication adherence barriers 
identified as relevant by the patient participant during the baseline survey; sent 
randomly within a window of time identified as convenient by the patient 
participant 
• 
1 daily interactive medication assessment messages sent shortly before the 
patient participants’ bedtime (e.g., “Did you take all of your diabetes medications 
as directed today, Tues, Jan 18, 2022? Please reply Yes or No.”) 
• 
1 weekly interactive text asking about goal progress to be followed by feedback 
text from coach within the next few days (e.g., “This week is done! Your SMART 
goal was to walk 20 mins each day for 6 days. What went well or got in your 
way? Reply with the number of days you met your goal and a brief reflection.”) 
 
Support persons received approximately 4-5 texts per week for 9 months: 
- 
3 to 4 one-way texts per week pertaining to supporting the patients’ self-care 
efforts and increasing dialogue about diabetes and health behaviors with the 
patient participant; tailored to the goal “type” set in the patient participant’s 
most recent coaching session; sent randomly within a window of time identified 
as convenient by the support person participant.   
- 
1 interactive text per week about supporting the patient participant in their 
diabetes self-care; sent at a time of day identified as convenient by the support 
person participant. Responses received an automated message. (e.g., “This week 
is done! Reflect on how you supported [patient participant name] this week. 
Reply with what went well or what could go better next week”; “How confident 
do you feel supporting [patient participant name] with her health goals? Please 
provide a rating from 1 to 5 where 1=not so confident and 5=very confident") 
 
Summary of Measures: 
Construct 
Instrument or Source 
Patient Participants 
Outcomes 
Hemoglobin A1c 
(primary outcome) 
Venipuncture or point-of-care device used in regular clinical care 
collected from the electronic medical record or collected via mail-
in kit from CoreMedica 
Psychosocial Well-being (secondary outcome) 
Diabetes Distress 
Problem Areas in Diabetes (PAID) with scores ranging 0 to 100 
where higher scores indicate more emotional, psychological and 
social distress related to diabetes management (worse) 
Global Well-Being 
World Health Organization – Five Well-Being Index (WHO-5) with 
scores ranging 0 to 100 where higher scores indicate better 
global mental wellbeing (better) 
Intervention Targets/Hypothesized Mediators 
Diabetes Self-
Perceived Diabetes Self-Management Scale (PDSMS) with scores 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
efficacy 
ranging 8 to 40 with higher scores indicating more self-efficacy 
(better) 
Diabetes Self-care 
Dietary Behavior 
Personal Diabetes Questionnaire (PDQ) scales: 
Problem Eating Behavior with scores ranging 1-6 where higher 
scores indicate more problem eating behaviors (worse) 
Use of Information for Dietary Decision Making with scores 
ranging 1-6 where higher scores indicate more use of dietary 
information for decision making (better)  
Physical Activity 
Modified version of the Rapid Assessment of Physical Activity 
(RAPA) with scores ranging 0 to 6533 with higher scores 
indicating more physical activity (better) 
Medication 
Adherence 
Adherence to Refills and Medications Scale for Diabetes (ARMS-
D) with scores ranging 11-44 with higher scores indicating more 
problems with adherence (worse) 
Summary of Diabetes Self-Care Activities medications subscale 
(SDSCA-MS) with scores ranging 0 to 7 representing days in the 
prior week with perfect adherence (higher better) 
Diabetes-specific Family/friend Involvement 
Helpful Involvement 
Family/friend Involvement in Adults’ Diabetes (FIAD) helpful 
scale assessing helpful behaviors over the past month with 
scores ranging 1 to 5 with higher scores indicating more helpful 
behaviors from family/friends (better) 
Important Others Climate Questionnaire specific to diabetes 
management, with scores ranging 1 to 5 with higher scores 
indicating more autonomy supportive communication (better) 
Harmful Involvement 
Family/friend Involvement in Adults’ Diabetes (FIAD) harmful 
scale assessing harmful behaviors over the past month with 
scores ranging 1 to 5 with higher scores indicating more harmful 
behaviors from family/friends (worse) 
Perceived Criticism specific to diabetes management assessed 
with items from the Family Emotional Involvement and Criticism 
Scale with scores ranging 0 to 16 with higher scores indicating 
more perceived criticism related to diabetes management 
(worse) 
Potential Moderators 
Race and ethnicity 
Participants self-report Hispanic ethnicity and race(s) 
Socioeconomic 
disadvantage 
Indicator variable calculated based on self-reported education 
(<12 years), health insurance (uninsured or public insurance 
only), or annual household income (<$50,000 USD) 
Gender 
Male, Female, Other self-reported gender 
Cohabitating with 
support person 
Whether or not the patient participant and support person life 
together  
Support Person (SP) 
Outcomes 
Diabetes Distress 
Family Members Problem Areas in Diabetes (PAID-FM) from the 
Diabetes Attitudes, Wishes, and Needs Second study (DAWN2) 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
with scores ranging 0-100 where higher scores indicate more 
distress about the PWDs’ diabetes experienced by the support 
person (worse) 
Support Burden 
DAWN2 Family Burden Item which asks how much of a burden it 
is to help the PWD manage their diabetes, with responses on a 
scale from 0 (no burden) to 4 (a very large burden; worse) 
Intervention Targets 
Support Person Involvement 
Helpful Involvement 
Family member version of the Family/friend Involvement in 
Adults’ Diabetes (FIAD-FM) helpful scale assessing the support 
person’s own performance of helpful behaviors over the past 
month with scores ranging 1 to 5 with higher scores indicating 
more helpful behaviors (better) 
Harmful Involvement  
Family member version of the Family/friend Involvement in 
Adults’ Diabetes (FIAD-FM) harmful scale assessing the support 
person’s own performance of harmful behaviors over the past 
month with scores ranging 1 to 5 with higher scores indicating 
more harmful behaviors (worse) 
Alignment between 
desired and actual 
involvement 
Items from the DAWN2 Family Experience of Patient Involvement 
measure. Scores range 0 to 4 where a score of 2 indicates 
alignment between the support person's current level of 
involvement and their desired level of involvement 
Potential Moderators 
Race and ethnicity 
Participants self-report Hispanic ethnicity and race(s) 
Gender 
Male, Female, Other self-reported gender 
Cohabitating with 
patient participant 
Whether or not the patient participant and support person live 
together 
 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
 
We have a Data and Safety Monitoring Board (DSMB) comprised of physicians and 
scientists who do related research among adults with diabetes. The PI and study 
coordinator are responsible for reviewing study components for data completeness and 
protocol compliance. The PI is responsible for meeting regularly with the study team 
throughout the RCT to discuss the study timeline, recruitment and enrollment, and any 
participant concerns. The PI and study coordinator are responsible for reviewing study 
components for data completeness and protocol compliance, evaluating patient 
concerns, and if applicable, reporting any serious adverse events or unanticipated 
problems involving risks to participants to the DSMB, IRB, and NIH. The PI would report 
any serious adverse events or unanticipated problems involving risks to participants to 
the DSMB, IRB, and NIH per IRB policy. If changes were made to the protocol, an 
amendment was submitted to the IRB. An annual progress report is submitted annually 
to the NIH. 
 
The PI also provides the DSMB with reporting on recruitment and enrollment, 
recruitment, intervention engagement, study timeline and milestones, and any adverse 
events or protocol deviations via a written report every 6 months, and a meeting as 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
needed to discuss challenges or an adverse event. The DSMB reviewed reporting, made 
recommendations if needed, and signed a letter affirming their review and itemizing 
recommendations (if any). 
 
7.0 
Study Withdrawal/Discontinuation 
 
During the enrollment phase, persons with diabetes who did not return their baseline 
survey after 5 weeks and were unresponsive to research staff communication were 
administratively withdrawn. If persons with diabetes were not reached for their condition 
assignment call within one month, then they and their support person (if applicable) 
were administratively withdrawn. 
 
If a participant expressed wishes to withdrawal from the study, study staff would 
contact the participant. Study staff followed a protocol to determine which levels of 
participation the patient does/does not want:  
(1) limited intervention (e.g., no text messages but willing to complete coaching 
if so assigned) but will complete study assessments 
(2) no intervention (opt out of all assigned study components) but will complete 
study assessments 
(3) no surveys but okay with completing A1c kits or vice versa and receiving 
assigned components 
(4) no surveys nor A1c tests but will allow study staff to review and extract 
relevant data to the study from their EMR 
(5) no further participation 
If a SP expressed that they did not want to participate in the study, study staff followed 
a protocol to determine what level of participation they do/do not want:  
(1) limited intervention – no text messages but will complete study assessments 
(2) no surveys but okay with receiving text messages 
(3) no further participation 
Patients can still engage with all aspects of the study if their SPs withdraws. If the 
patient withdraws to the level of no further participation, their SP would be 
administratively withdrawn. If a SP withdraws to the level of no further participation, we 
would contact their patient partner to let them know their SP has withdrawn completely 
from the study. If a support person withdraws for any reason, the patient participant 
could identify another support person to participate in the study with them.  
 
If a participant expressed wishes to withdrawal and could not be reached by study staff 
to confirm their level of withdrawal, the participant was treated as a full withdrawal with 
no further participation (option 5 from the list above.) 
 
8.0 
Statistical Considerations 
 
Power estimates were conservatively calculated based on a two-sample unequal 
variance t-test of 9-month A1c for a minimum detectible difference of 0.5%; we 
targeted enrollment of 334 dyads to obtain sufficient effective sample size to detect this 
effect. Allowing for a dropout rate of ∼15%, an effective sample size of 284 (∼142 per 
condition) provides 80% power to detect this minimum difference at a 5% significance 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
level assuming a standard deviation of 1.5%. For secondary outcomes and mediators, 
assuming skewness similar to A1c (in general it will be less) and retention of 80–90%, 
we will be able to detect standardized effect sizes of 0.32–0.34. Estimates of detectable 
effect were made via 40,000 simulations with a Beta distribution calibrated to 
approximate skewness similar to that observed in our prior work. 
 
Our power will be greater than estimates, given our plans to use data imputation 
methods for missing data, and adjust for baseline values of the outcome(s) of interest 
and other covariates as needed per analysis, which should increase power by reducing 
the effective standard deviation of the outcome.   
 
9.0 
Privacy/Confidentiality Issues 
 
Only key study personnel (KSP) approved by the IRB have access to research 
information. Participant survey and phone coaching data was entered and stored 
electronically in REDCap. KSP assigned participants a unique subject ID associated with 
their identifiable information in REDCap. Original paper copies of any surveys or 
coaching notes were deidentified and filed in a locked file cabinet. Participant contact 
information is password protected in a REDCap database and on a secure VUMC server. 
Patient information collected for payment purposes is stored separately from research 
data in a locked file cabinet. Only select participant data from REDCap was securely and 
automatically transferred to CareWire, whose platform delivers the mobile phone 
intervention, to initiate and tailor the intervention (e.g., name, cell phone number, 
birthdate, preferred time of day to receive text messages, patient's self-care 
goal set during coaching, study A1c). Individual participant responses to text messages 
were only accessible by KSP through a secure password-protected portal.  
 
10.0 Follow-up and Record Retention 
 
The study duration is 3 years (recruitment start through last follow-up assessment for all 
participants). KSP assigned participants a unique subject ID associated with their 
identifiable information in REDCap. De-identified data is stored on a secure VUMC server 
and retained for at least ten years after the close of the study. CareWire provided de-
identified reports to KSP to monitor the content and delivery of text messages and 
participant engagement, which are retained on a secure VUMC server for at least ten 
years after the close of the study. Participant contact information is password protected 
and stored separately, without any health information, on a secure VUMC server for one 
year following the close of the study, at which point it will be destroyed. Patient 
information collected for payment purposes is stored separately from research data in a 
locked file cabinet and destroyed upon study closure. Participant contact information for 
those participants who want to be contacted for future research studies is stored on a 
secure VUMC server and password protected.  

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
15.0 Background 
 
In November 2020 – less than half-way through recruitment for the FAMS 2.0 
RCT, we applied for a competing revision to NIH to support expanding the aims 
of the original R01 to include secondary data analyses from the FAMS 2.0 RCT 
and exit interviews. 
 
Using cluster analysis with data from a large cohort of adults with T2DM, we 
identified 4 types of diabetes-specific family functioning. Type was independently 
associated with diabetes outcomes, including glycemic control (primary outcome 
of FAMS 2.0 RCT) and psychosocial wellbeing (diabetes distress and global well-
being, secondary outcomes of FAMS 2.0 RCT). Because this evidence suggests 
effects of the FAMS 2.0 intervention may vary by type of diabetes-specific family 
functioning, we added the typology assessment measures to the RCT surveys. 
This addition will allow us to explore type as a moderator of intervention 
engagement and effects. The addition of exit interviews will help inform future 
intervention efforts by type. 
 
The aims of the FAMS 2.0 RCT are unchanged.  
 
16.0 Rationale and Specific Aims 
 
Aim 1. Validate the diabetes-specific family functioning typology 
longitudinally in a diverse sample to:  
1a. Determine if similar types emerge in the more diverse RCT sample at baseline.   
1b. Examine type stability over time in the control group.  
1c. Examine associations between type and outcomes prospectively in the control 
group. Findings will enhance the utility of the typology in diverse samples and the 
clinical validity of the typology.  
Aim 2. Explore diabetes-specific family functioning type as an effect modifier 
of FAMS 2.0. We will use mixed methods to understand how efficacy of the FAMS 2.0 
intervention was moderated by baseline type. 
2a. Examine effect modification by type over the 15-month RCT and explore which 
components of the intervention were/were not engaging for each type. 
2b. Complete exit interviews with n=80 intervention participants using rolling purposive 
sampling to ensure representation of each type.  
 
Upon completion of these aims, we will know how to identify patients for whom the 
FAMS 2.0 intervention will be maximally effective to inform future implementation efforts 
and we will have hypotheses about what intervention components may maximize effects 
for other patients in the future. 
 
17.0 Study Procedures 
 
Procedure/Activity 
Frequency 
Survey (patient participants) 
Baseline, 6mo, 9mo, 15mo – same as for 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
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the FAMS 2.0 RCT 
Exit Interviews 
Upon completion of the study (15mo) 
participants assigned to intervention were 
invited to participate in an exit interview 
 
Each patient participant survey for the FAMS 2.0 RCT included measures of the typology 
dimensions. 
 
Measures of Dimensions for Typology 
For these items, respondents are asked to "think about the person who is most involved 
in your diabetes on a regular basis." 
Collaborative Coping (3 
dimensions): Cognitive 
Compensation, 
Interpersonal Enjoyment, 
& Frequency  
Perceptions of Collaboration Questionnaire (PCQ) assesses 
Cognitive Compensation (degree to which collaboration is 
needed to overcome cognitive deficits or decline; α=0.80), 
Interpersonal Enjoyment (degree to which collaboration 
provides encouragement and closeness; α=0.64), and 
Frequency of Collaboration (α=0.79) 
For these items, "think about the people closest to you in your everyday life - it doesn't 
matter if they live with you." 
Received support (2 
dimensions): helpful & 
harmful  
Family/Friend Involvement in Adults’ Diabetes (FIAD) 
assesses the helpful and harmful aspects of received support 
for diabetes self-care activities in the past 30 days. 9-items 
assess helpful (e.g. “How often do your family members 
exercise with you or ask you to exercise with them?”; 
α=0.87) and 7-items assess harmful (e.g. “How often do 
your family members bring foods around that you shouldn’t 
be eating?”; α=0.72). Harmful items query frequency of 
undermining/ sabotaging behaviors and nagging/arguing 
about self-care  
Perceived support: 
Autonomy Support 
Important Other Climate Questionnaire (IOCQ) assesses 
perception of the degree to which others support the 
individual’s personal agency. We adapted the 6-item IOCQ 
to be specific to diabetes as the developers recommend and 
to reference more than one important other (e.g. “My 
important others try to understand how I see my diabetes 
before suggesting any changes”; α=0.89) 
Perceived support: 
Criticism 
The criticism scale from the Family Emotional Involvement 
and Criticism Scale, adapted to be specific to diabetes (e.g. 
“My important others find fault with the things I do to 
manage my diabetes”; α=0.71) 
Match (2 dimensions): 
Effectiveness & 
Satisfaction 
Single items: “How effective are your friends and family at 
dealing with troubles or issues related to your diabetes 
management?”; "How satisfied are you with your friends 
and family members' involvement in dealing with troubles or 
issues related to your diabetes management?" 
 
Only patient participants assigned to the intervention are recruited for exit interviews. 

FAMS 2.0 (PI: Mayberry) 
R01-DK119292 
NCT04347291 
Version date: 10/24/2021 
Following the 15-month follow-up period, some intervention participants will be asked to 
participate in an exit interview to collect feedback about the intervention and learn 
about their experience. We will use baseline data from the RCT to purposively sample 
n=80 participants to complete interviews, such that n=15-20 represent each of the four 
typology types. Exit interviews are completed over the telephone, last ~30-45 minutes, 
and participants will provide verbal informed consent before any interview data is 
collected. Questions focus on (a) diabetes-specific family functioning prior to, during and 
after the intervention, (b) which intervention components they felt worked best/least for 
them, and (c) desirability and acceptability of alternative intervention formats and 
content. 
Participants who complete an interview are compensated $40. Interviews are audio 
recorded and transcribed for analysis. 
 
18.0 Statistical Considerations 
 
This analysis leverages the outcomes measures data already collected during the RCT, 
including: hemoglobin A1c, diabetes distress, global well-being, self-efficacy, self-care 
behaviors (dietary behavior, physical activity, medication adherence) and helpful and 
harmful family/friend involvement.  
 
This analysis leverages engagement data already collected during the RCT, including: 
enrollment of a support person, text message response rates, coaching session 
completion rates, elements of coaching protocol including completing rates of goals set, 
completion of verbal contract to engage friends/family. 
 
The FAMS 2.0 RCT was not designed to test effect modification or moderation by type. 
Tests of effect modification are exploratory and intended for hypothesis generation, 
therefore we will interpret patterns of effects and use p<.10 as our threshold to discern 
potentially meaningful differences in intervention effects.  
 
19.0 Privacy/Confidentiality Issues 
 
Informed consent for patient participant exit interviews is obtained verbally over the 
phone before completing the exit interview. Exit interviews are recorded following 
participants' consent and the audio files and transcripts are stored using the subject's 
unique ID on a secure VUMC server. The transcripts are de-identified and will be stored 
separately from other participant data for at least ten years after the close of the study. 
Recorded exit interviews will be stored separately, on a secure VUMC until the close of 
the study, at which point they will be destroyed.