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| Name | Class |
|---|---|
| Harvard University | OTHER |
| Vinfen | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDTA-IIMR | Experimental |
| |
| Peer support | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer-delivered and Technology Support Integrated Illness Management and Recovery | Behavioral | PDTA-IIMR is delivered by a peer support specialist with the use of guided IIMR eModules and a smartphone application designed to complement in-person eModule sessions. The eModules are designed to be reviewed with a peer support specialist and consumer during one-hour, weekly, telephonic sessions in a community setting. Each eModule includes videos and experiential learning tasks on psychoeducation and coping skills training. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of study drop-outs, attendance, and adherence from baseline to 3-months | Review case notes written by peer support specialists to examine count data on attrition, attendance, and patient adherence. | Baseline and 3-months |
| Change in average fidelity scores | Peer Support specialists will independently rate themselves after each session using the PDTA-IIMR fidelity scale. The standards used for establishing the items and ratings were determined by expert sources and empirical research. | Baseline and 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline mortality risk index to 3-months and 6-month follow-up | Avoidable Mortality Risk Index includes an examination of modifiable risk factors include: smoking; high blood pressure; excess body weight; high blood glucose; high cholesterol; high alcohol intake; low physical activity; poor diet. | Baseline, 3-months, and 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline level of loneliness to 3-months and 6-month follow-up | UCLA Loneliness Scale. For loneliness each of the three-item version of the UCLA Loneliness Scale are rated on a four-point scale, with higher values indicative of greater loneliness. Items asked about how often individuals felt left out and isolated from others, and how often they felt that there are people that really understand them or that they can talk to. |
Consumer Inclusion Criteria
Consumer eligibility includes the following:
Consumer Exclusion Criteria
Consumer participants will be excluded based on the following criteria:
Peer Inclusion Criteria
Peer eligibility includes the following:
Peer Exclusion Criteria
Peer participants will be excluded based on the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinfen | Cambridge | Massachusetts | 02141 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40755935 | Derived | Fortuna KL, Cui S, Lebby S, Xie H, Bruce ML, Bartels SJ. PeerTECH: a randomized controlled trial of a peer-led mobile health intervention to improve medical and psychiatric self-management for persons with serious mental illness. Mhealth. 2025 Jun 30;11:28. doi: 10.21037/mhealth-24-64. eCollection 2025. |
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Tools (data, assays, libraries, research tools, reagents, model organisms, etc.) will be made available, in accordance with the NIH Data Sharing Policy (http://grants.nih.gov/grants/policy/data\_sharing) and Model Organism Sharing Policy (http://grants.nih.gov/grants/policy/model\_organism/index.htm), to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. In some cases the Trustees of Dartmouth College (the institution) may determine that the public and the research community are better served by a licensing program whether or not patents have been filed. This may be relevant, for example, if a tool is best distributed under license to guarantee reagent availability and quality.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 24, 2025 | |
| Reset | May 9, 2025 | |
| Release | Jul 16, 2025 |
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|
| Peer support | Behavioral | Peer support is a non-manualized form of social support, frequently coupled with instrumental support, that is mutually offered or provided by persons having a mental health condition to others sharing a similar mental health condition to bring about a desired social or personal change. Peer support specialists are provided with 1-hour of supervision each week |
|
| Change from baseline self efficacy to 3-months and 6-month follow-up | Self-Efficacy for Managing Chronic Disease. Self-Efficacy for Managing Chronic Disease is a six-item scale that assesses domains of self-efficacy: symptom control, role function, emotional functioning, and communicating with physicians. Higher scores indicate greater self-efficacy. | Baseline, 3-months, and 6-months |
| Change from baseline social support to 3-months and 6-month follow-up | Medical Outcomes Study Social Support Survey. Medical Outcomes Study Social Support is a 19-item scale that assesses domains of social support: emotional/informational, tangible, affection, and positive social interaction. Higher scores indicate higher levels of social support. | Baseline, 3-months, and 6-months |
| Change from baseline mental health self-management skills to 3-months and 6-month follow-up | Illness Management and Recovery Scale. The Illness Management and Recovery Scale is a valid, reliable 15-item scale that assesses domains of illness management. Each item addresses psychiatric illness, management, and recovery. Higher scores equate to higher ability to manage psychiatric conditions. | Baseline, 3-months, and 6-months |
| Change from baseline medical self-management skills to 3-months and 6-month follow-up | Self-Rated Abilities for Health Practices Scale.The Self-Rated Abilities for Health Practices Scale is a 28-item scale that assesses confidence to execute health practices that has shown reliability and validity with adults with disabilities. This scale includes four subscales: exercise, nutrition, responsible health practice, and psychological well-being. Higher scores indicate higher levels of self-efficacy. | Baseline, 3-months, and 6-months |
| Change from baseline functional ability to 3-months and 6-month follow-up | PROMIS Global Health. The PROMIS Global Health includes 10-items that measures five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). The measure is agnostic, rather than disease-specific, and commonly used to show an individuals' assessment of their overall health. Higher scores indicate better functional ability. | Baseline, 3-months, and 6-months |
| Change from baseline disability to 3-months and 6-month follow-up | London Handicap Scale. The London Handicap Scale measures health status and includes domains of independent living skills: mobility, physical independence, occupation, social integration, orientation, and economic self-sufficiency. Higher scores indicate better functional ability. | Baseline, 3-months, and 6-months |
| Change from baseline level of cardiovascular disease risk to 3-months and 6-month follow-up | Framingham Risk Score. Framingham Risk Score includes risk factors: age; sex; LDL cholesterol; HDL cholesterol; blood pressure; diabetes; and smoking. A higher score indicates worse outcomes. | Baseline, 3-months, and 6-months |
| Baseline, 3-months, and 6-months |
| Change from baseline patient satisfaction to 3-months and 6-month follow-up | Adult Patient Satisfaction Survey. The 36-item Adult Patient Satisfaction Survey designed to measure patient satisfaction in receiving mental health services in a community-based mental health system. Higher scores indicate greater patient satisfaction. | Baseline, 3-months, and 6-months |
| Reset | Aug 7, 2025 |
| Release | Nov 19, 2025 |
| Reset | Dec 11, 2025 |
| Release | Feb 4, 2026 |
| Reset | Feb 20, 2026 |
| Release | Mar 17, 2026 |
| Reset | Apr 3, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2025 | May 9, 2025 | |||
| Jul 16, 2025 | Aug 7, 2025 | |||
| Nov 19, 2025 | Dec 11, 2025 | |||
| Feb 4, 2026 | Feb 20, 2026 | |||
| Mar 17, 2026 | Apr 3, 2026 | |||
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D012008 | Recurrence |
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D012907 | Smoking |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D003866 | Depressive Disorder |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D016879 | Salvage Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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