Community Health Workers Against COVID19 Tackling Psychosocial Suffering Due to Physical Distancing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in patient-reported anxiety (based on the PROMIS® anxiety instrument)
研究概览
简要总结
Randomized controlled trial among patients from family practices at risk of psychosocial suffering due to social distancing measures. Patients from the intervention group receive support from community health workers. contacted at least 8 times by community health workers. Evolution of psychosocial wellbeing is evaluated by questionnaires at time 0 and after 6 weeks of intervention. Psychosocial outcomes are compared between control and intervention groups. Process evaluation will be done through in-depth interviews.
详细描述
Patients vulnerable for psychosocial suffering due to social distancing measures are recruited by family practitioners in the City of Ghent. The recruited patients are randomly selected into a control and intervention group. Based on the validated Promis instruments, all participants are interviewed face to face on their mental and social health at time 0 and after 6 weeks of intervention. Patients from the intervention group are contacted by Community health workers after the first interview. Community health workers offer emotional support to the patients through at least 8 contacts over 6 weeks. The control group receive care as usual and are offered support by community health workers after the second interview. In depth interviews (qualitative study) will be conducted among community health workers and patients after finalizing the post-intervention questionnaires.
Research questions: What are the psychosocial consequences of social distancing for at-risk groups? Can community health workers reduce the psychosocial impact of physical distancing measures isolation?
Relevance: Understanding community-based psychosocial support for vulnerable people during and after health crises.
Keywords: Community health workers, psychosocial, health crises
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients recruited by family practitioners based on anticipated psychosocial impact of physical distancing measures
排除标准
- •Patients with severe psychiatric diseases (psychosis, severe depression)
结局指标
主要结局
Change in patient-reported anxiety (based on the PROMIS® anxiety instrument)
时间窗: change from baseline at 6 weeks
The PROMIS Anxiety questionnaire assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).
Change in patient-reported Ability to participate in social roles and activities (based on the PROMIS® ability to participate in social roles and activities instrument)
时间窗: change from baseline at 6 weeks
The PROMIS adult Ability to Participate in Social Roles and Activities questionnaire assesses the perceived ability to perform one's usual social roles and activities.
Change in patient-reported Social Isolation (based on the PROMIS® Emotional Support instrument)
时间窗: change from baseline at 6 weeks
The PROMIS Social Isolation questionnaire assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others.
Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument)
时间窗: change from baseline at 6 weeks
The PROMIS Emotional Support questionnaire assesses perceived feelings of being cared for and valued as a person;
次要结局
未报告次要终点