跳至主要内容
临床试验/NCT04481737
NCT04481737已完成不适用

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

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in average fidelity scores

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in average fidelity scores

时间窗: Baseline 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-months

时间窗: Baseline and 3-months

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

次要结局

  • Change from baseline disability to 3-months and 6-month follow-up(Baseline, 3-months, and 6-months)
  • Change from baseline mortality risk index to 3-months and 6-month follow-up(Baseline, 3-months, and 6-months)
  • Change from baseline mental health self-management skills to 3-months and 6-month follow-up(Baseline, 3-months, and 6-months)
  • Change from baseline functional ability to 3-months and 6-month follow-up(Baseline, 3-months, and 6-months)
  • Change from baseline level of cardiovascular disease risk to 3-months and 6-month follow-up(Baseline, 3-months, and 6-months)
  • Change from baseline self efficacy to 3-months and 6-month follow-up(Baseline, 3-months, and 6-months)
  • Change from baseline social support to 3-months and 6-month follow-up(Baseline, 3-months, and 6-months)
  • Change from baseline medical self-management skills to 3-months and 6-month follow-up(Baseline, 3-months, and 6-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen L. Fortuna

Assistant Professor

Dartmouth-Hitchcock Medical Center

研究点 (2)

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