A Community Health Worker-Led Program for Chronic Pain and Loneliness in Older Adults

Официальное название

Targeting Loneliness in the Context of Chronic Pain Self-Management: An Intervention for Older Adults Living in Rural Areas

Обзор

The goal of this clinical trial is to test a new community health worker-delivered program (Strengthening COnnections to Overcome Pain, or SCOOP) that teaches strategies for managing chronic pain and loneliness to older adults living in rural areas. The main questions it aims to answer are: 1. Does participating in SCOOP result in less pain interference with daily life? 2. Does participating in SCOOP result in decreased loneliness? 3. What is the level of participant engagement in SCOOP? Researchers will compare people who have participated in SCOOP with people who have not participated in SCOOP to see if SCOOP is helpful in decreasing pain interference and loneliness. Participants will: 1. Watch brief videos teaching strategies to manage pain and boost social connections. 2. Engage in up to 7 weekly coaching sessions with a community health worker. 3. Complete two telephone interviews about health, mental health, and functioning: one at baseline, and one 2 months later.

Вмешательства

• Поведенческое Strengthening COnnections to Overcome Pain (SCOOP)
  Each week for 7 weeks, SCOOP intervention group participants will watch a brief video on the study website teaching a pain management or social connectedness skill and have a session with a community health worker, where they will receive support with behavioral goal-setting related to pain management and/or social connections. Participants will be screened for unmet social needs and connected to appropriate resources.

Первичные конечные точки

• Engagement as measured by number of sessions completed [Срок оценки: 8 weeks from baseline]

Вторичные конечные точки (3)

• Participant satisfaction with the SCOOP intervention [Срок оценки: 8 weeks from baseline]
• Change in Loneliness as measured by the UCLA 8-item Loneliness Scale [Срок оценки: Baseline, 8 weeks from baseline]
• Change in Pain Interference 6-item subscale from PROMIS-43 Adult Profile [Срок оценки: Baseline, 8 weeks from baseline]

Критерии участия

Критерии включения

• Age >= 60 years;
• Have a mobile or landline phone;
• Self-reported chronic musculoskeletal pain (pain in muscles or joints for >= 3 months, >=4 (0-10 scale) average pain level over last week, >=1 day/previous 30 when pain made it difficult to do usual activities);
• Self-reported loneliness (Feeling lonely "some of the time" or more often);
• Able to converse comfortably in English.

Критерии исключения

• Serious acute illness or hospitalization in the last month;
• Planned major surgery in the next three months that would interfere with program participation (e.g., knee or hip replacement);
• Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose a significant barrier to participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06671925 · HUM00261437 · P30AG022845

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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