MedPath

Peer-delivered and Technology-Assisted Integrated Illness Management and Recovery

Not Applicable
Completed
Conditions
Schizophrenia
Obesity
Blood Pressure Disorders
Major Depressive Disorder, Recurrent
Cardiovascular Diseases
Diabetes
Cholesterol, Elevated
Bipolar Disorder
Smoking
Interventions
Behavioral: Peer-delivered and Technology Support Integrated Illness Management and Recovery
Behavioral: Peer support
Registration Number
NCT04481737
Lead Sponsor
Dartmouth-Hitchcock Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PDTA-IIMRPeer-delivered and Technology Support Integrated Illness Management and Recovery-
Peer supportPeer support-
Primary Outcome Measures
NameTimeMethod
Change in average fidelity scoresBaseline and 3-months

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.

Change in number of study drop-outs, attendance, and adherence from baseline to 3-monthsBaseline and 3-months

Review case notes written by peer support specialists to examine count data on attrition, attendance, and patient adherence.

Secondary Outcome Measures
NameTimeMethod
Change from baseline disability to 3-months and 6-month follow-upBaseline, 3-months, and 6-months

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.

Change from baseline mortality risk index to 3-months and 6-month follow-upBaseline, 3-months, and 6-months

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.

Change from baseline mental health self-management skills to 3-months and 6-month follow-upBaseline, 3-months, and 6-months

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.

Change from baseline functional ability to 3-months and 6-month follow-upBaseline, 3-months, and 6-months

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.

Change from baseline level of cardiovascular disease risk to 3-months and 6-month follow-upBaseline, 3-months, and 6-months

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.

Change from baseline self efficacy to 3-months and 6-month follow-upBaseline, 3-months, and 6-months

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.

Change from baseline social support to 3-months and 6-month follow-upBaseline, 3-months, and 6-months

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.

Change from baseline medical self-management skills to 3-months and 6-month follow-upBaseline, 3-months, and 6-months

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.

Trial Locations

Locations (1)

Vinfen

🇺🇸

Cambridge, Massachusetts, United States

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