Improving Physical and Psychosocial Functioning in Older Adults: A Community Health Worker-Led Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 1
- 主要终点
- Change in PROMIS-29 Mental (Psychosocial) Summary Score
研究概览
简要总结
The heightened vulnerability to COVID-19 of African American older adults in Detroit, Michigan and other marginalized communities is linked to systemic racism experienced over the life course. Structural inequities also magnify the pandemic's impact on older adults' physical and psychosocial functioning. Many older adults in Detroit, burdened by poor health even before the pandemic, face a downward spiral of increased distress, reduced physical and social activity, and physical deconditioning. RESET (Re-Engaging in Self-care, Enjoying Today) is a self-management and resilience-building intervention led by community health workers (CHWs) at the Detroit Health Department (DHD). The central hypothesis of this study is that RESET, with components that include group telephone calls, a podcast series, and activity trackers, will improve psychosocial and physical functioning at 2 and 8 months. Specific aims are: 1) With input from a Community Advisory Board, modify RESET for group delivery and refine content after testing in a mini-pilot (n=10). 2) Conduct a randomized, controlled trial to assess the impact of RESET (compared to a one-time /telephone wellness check) on PROMIS-29 Psychosocial Score (a weighted combination of distress, fatigue, pain, social participation and sleep) among 456 primarily African American older adults age 50 and over who are at elevated risk of poor functioning. 3) Collect qualitative (interview) data from participants and other stakeholders, and use this data to better understand trial results, as well as to assess community impact and inform a dissemination toolkit.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any elevated physical or psychosocial symptoms as follows:
- •Depression: Score ≥3 on the Patient Health Questionnaire-2 (PHQ-2); Anxiety: Score >= 3 on the GAD-2 anxiety screening scale; Fatigue: Rating >=4 on a 0 to 10 scale (0 = fatigued at all and 10 = extremely fatigued); Loneliness, as indicated by a score >=6 on 3-item UCLA Loneliness Scale; Perceived stress, as indicated by a mean score >3 on the Perceived Stress Scale-4; Chronic pain: Self-reported pain in muscles or joints for >3 months, >4 (0-10 scale) mean pain intensity over last month, and >=1 day in past month when pain made it difficult to do usual activities.
- •Have a cell or landline phone.
- •Able to converse comfortably in English.
排除标准
- •Serious acute illness or hospitalization in last month.
- •Planned major surgery in next three months that would interfere with program participation (e.g., knee or hip replacement).
- •Severe cognitive impairment or dementia.
- •Any other diseases or conditions that would impair cooperation with the study team or ability to complete study procedures, as determined by the clinicians on the investigative team. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction).
研究组 & 干预措施
RESET intervention
Participants will engage in a 7-week positive psychology and self-management group telephone-based program.
干预措施: RESET (Behavioral)
Wellness check control
Participants will receive educational information and an individual wellness check phone call from a Community Health Worker to screen for unmet social needs.
干预措施: Wellness Check Control (Behavioral)
结局指标
主要结局
Change in PROMIS-29 Mental (Psychosocial) Summary Score
时间窗: Baseline, 2 months from baseline, and 8 months from baseline
Brief Description: The PROMIS-29 Mental (Psychosocial) Summary Score is a weighted composite of distress (depression and anxiety), pain (intensity and interference), social participation, fatigue, and sleep. Weights are provided in Hays et al (2018), "PROMIS-29 v2.0 profile physical and mental health summary scores", Quality of Life Research, 1885-1891. Scores are standardized on a T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means more of the concept being measured.
次要结局
- Change in PROMIS-29 Physical Summary Score(Baseline, 2 months from baseline, and 8 months from baseline)
- Change in Connor-Davidson Resilience Scale(Baseline, 2 months from baseline, and 8 months from baseline)
- Patient Global Impression of Change (Functioning)(2 months from baseline, and 8 months from baseline)
研究者
Mary Janevic
Research Associate Professor
University of Michigan