Clinical trial NCT05451589: A Trial of a Positive Psychology Intervention for Older Adults (RESET) During the COVID-19 Pandemic
Official title: Improving Physical and Psychosocial Functioning in Underserved Older Adults During the COVID-19 Pandemic: A Community Health Worker-Led Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Chronic Pain
Fatigue
Loneliness
Stress, Psychological
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Detroit Department of Health
First posted: 2022-07-11
Enrollment: 456
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in PROMIS-29 Mental (Psychosocial) Summary Score
timeFrame: Baseline, 2 months from baseline, and 8 months from baseline
Secondary outcomes:
measure: Change in PROMIS-29 Physical Summary Score
timeFrame: Baseline, 2 months from baseline, and 8 months from baseline
measure: Patient Global Impression of Change (Functioning)
timeFrame: 2 months from baseline, and 8 months from baseline
measure: Change in Connor-Davidson Resilience Scale
timeFrame: Baseline, 2 months from baseline, and 8 months from baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: