Clinical trial NCT04481737: Peer-delivered and Technology-Assisted Integrated Illness Management and Recovery
Official title: Peer-delivered and Technology-Assisted Integrated Illness Management and Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Major Depressive Disorder, Recurrent
Obesity
Cardiovascular Diseases
Diabetes
Smoking
Blood Pressure Disorders
Cholesterol, Elevated
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Vinfen
First posted: 2020-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adults with serious mental illness (SMI) are disproportionately affected by medical comorbidity, earlier onset of disease, and 10 to 25 years reduced life expectancy compared to the general population. These high rates of morbidity and early mortality are associated with inadequately managed medical and psychiatric illnesses. A recent systematic review found nine effective self-management interventions that address medical and psychiatric illnesses in adults with SMI. However, there has been limited adoption of these interventions due to both provider and consumer-based factors. Provider-based barriers consist of the lack of an adequate workforce with the capacity, time, and knowledge of effective approaches to self-management support for adults with SMI and chronic health conditions. Consumer-based barriers associated with limited participation in self-management programs include lack of access, engagement, and ongoing community-based support for persons with SMI. Peer support specialists have the potential to address these barriers as they comprise one of the fastest growing sectors of the mental health workforce, have "lived experience" in self-management practices, and offer access to support in the community. However, challenges need to be resolved for peers to be effective providers of evidence-based interventions. For example, peers are frequently trained to provide "peer support" described as "giving and receiving help founded on key principles of respect, shared responsibility, and mutual agreement of what is helpful". Peer support has been associated with increased sense of control, ability to make changes, and decreased psychiatric symptoms. Despite benefits, peer support does not adhere to evidence-based practices for psychiatric and medical self-management and does not follow protocols that ensure fidelity and systematically monitor outcomes. The investigators hypothesize that mobile technology has the potential to overcome these limitations of peer support by providing real-time guidance in fidelity adherent delivery of a peer-delivered, technology-assisted evidence-based self-management intervention (PDTA-IIMR). The investigator will build the necessary expertise to pursue a career developing and testing novel approaches to peer-delivered evidence-based self-management interventions. Training will include: development of peer-delivered interventions; development and design of mobile health-supported interventions; and intervention clinical trials research. Concurrently, this study includes refinement of the intervention protocol with input from peers and consumers and conducting a pilot study evaluating the feasibility and potential effectiveness of PDTA-IIMR compared to routine peer support for N=6 peers and N=40 adults with SMI and chronic health conditions. Outcomes include feasibility, medical and psychiatric self-management skills, functional ability, and mortality risk factors and examine self-efficacy and social support as mechanisms on outcomes.


Eligibility criteria: Consumer Inclusion Criteria

Consumer eligibility includes the following:

* (1) participants will be adults age 18 or older who have a chart DSM-V Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, persistent major depressive disorder (diagnosis will be verified using the Mini-International Neuropsychiatric Interview);
* (2) have been enrolled in treatment for at least 3 months;
* (3) a chart diagnosis of a medical diagnosis of cardiovascular disease, obesity, diabetes, or chronic obstructive pulmonary disease;
* (4) speak and read English; and
* (5) voluntary informed consent for participation in the study by the participant.

Consumer Exclusion Criteria

Consumer participants will be excluded based on the following criteria:

* (1) chart diagnosis of dementia or documented cognitive impairment as indicated by the Mini Mental State Examination score \<24;
* (2) major visual, hearing, or motor impairment (measured by potential participants' ability to use a smartphone);
* (3) currently residing in a nursing home;
* (4) terminal illness expected to result of death of participant within one year; or
* (5) consumers with two or more emergency room or hospitalizations in the last 6 months or as determined by the clinical team to be psychiatrically or medically unstable;

Peer Inclusion Criteria

Peer eligibility includes the following:

* (1) Massachusetts certified peer specialist (i.e., to qualify to be a Massachusetts certified peer specialist a person must self-report any mental health diagnosis, be in active treatment, and complete an 80 hour training that includes classes, small group activities, and homework on fundamentals of peer support, cross-cultural partnering, and human experience language. All certified peer specialists must pass a written examination);
* (2) a clinical history of improved psychiatric and medical self-management in the past 6 months;
* (3) speak and read English;
* (4) willing to use technology to deliver an intervention;
* (5) must provide voluntary informed consent for participation in the study; and
* (6) have worked as a certified peer specialist with people with SMI for 1+ years.

Peer Exclusion Criteria

Peer participants will be excluded based on the following criteria:

* (1) chart diagnosis of dementia or documented cognitive impairment as indicated by the Mini Mental State Examination score \<24;
* (2) major visual, hearing, or motor impairment (measured by potential participants' ability to use a tablet); and
* (3) certified peer specialists with two or more emergency room or hospitalizations in the last 6 months or as determined by the clinical team to be psychiatrically or medically unstable.

Primary outcomes:
measure: Change in number of study drop-outs, attendance, and adherence from baseline to 3-months
timeFrame: Baseline and 3-months
measure: Change in average fidelity scores
timeFrame: Baseline and 3-months
Secondary outcomes:
measure: Change from baseline mortality risk index to 3-months and 6-month follow-up
timeFrame: Baseline, 3-months, and 6-months
measure: Change from baseline self efficacy to 3-months and 6-month follow-up
timeFrame: Baseline, 3-months, and 6-months
measure: Change from baseline social support to 3-months and 6-month follow-up
timeFrame: Baseline, 3-months, and 6-months
measure: Change from baseline mental health self-management skills to 3-months and 6-month follow-up
timeFrame: Baseline, 3-months, and 6-months
measure: Change from baseline medical self-management skills to 3-months and 6-month follow-up
timeFrame: Baseline, 3-months, and 6-months
measure: Change from baseline functional ability to 3-months and 6-month follow-up
timeFrame: Baseline, 3-months, and 6-months
measure: Change from baseline disability to 3-months and 6-month follow-up
timeFrame: Baseline, 3-months, and 6-months
measure: Change from baseline level of cardiovascular disease risk to 3-months and 6-month follow-up
timeFrame: Baseline, 3-months, and 6-months
Other outcomes:
measure: Change from baseline level of loneliness to 3-months and 6-month follow-up
timeFrame: Baseline, 3-months, and 6-months
measure: Change from baseline patient satisfaction to 3-months and 6-month follow-up
timeFrame: Baseline, 3-months, and 6-months
Locations:
city: Cambridge
country: United States
facility: Vinfen
state: Massachusetts
Study officials:
References: