Connecting Caregivers: A Randomized Controlled Trial to Evaluate Virtual Peer-Support for Family Caregivers of Individuals With Neuromuscular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS)
研究概览
简要总结
Competent family caregivers (FC) are essential for successful caring for individuals with NMD. However, family caregiving is known to contribute to significant FC burden and social isolation, and negatively affects FC health. Infrastructure to support FCs is paramount to ensure that individuals with NMD can safely remain at home. Individuals with NMD have complex health problems, require a lot of care and they use the healthcare system often. COVID-19 physical distancing has increased the care burden and social isolation for many FCs. Infrastructure to support FCs is paramount to ensure that individuals with NMD can safely remain at home. Peer support includes emotional and informational support by an individual that has experienced a similar health problem. It improves health-related quality of life, increases self-efficacy and empowerment, and decreases stress in various patient and caregiver populations. With our study we plan to educate and empower individuals with NMD and their caregivers and develop a comprehensive peer support program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria for Peer-Support Program:
- •Inclusion Criteria
- •FC of individual with NMD that lives in Canada;
- •Speaks and reads English;
- •Access to internet and computer/tablet.
排除标准
- •We will exclude those Ventilator Assisted Individuals (VAI) and caregivers, who are:
- •Unable to communicate verbally in English
- •No access to internet and computer/tablet.
- •Eligibility Criteria for Peer Mentors:
- •Inclusion Criteria:
- •Criteria 1-3 above;
- •Completion of virtual peer support training;
- •Identified by the HMV team or self-referral.
- •Exclusion Criteria:
- •We will exclude those VAIs and caregivers, who are:
- •Unable to communicate verbally in English
- •No access to internet and computer/tablet.
研究组 & 干预措施
Intervention
After informed consent, we will assign participants in a 1:1 ratio to the intervention or control group using Randomize.net.
Participants randomized to intervention group will get access to the Virtual Peer Support Program.
干预措施: The Virtual Peer Support Program (Behavioral)
Control
Control group: Those randomized to the waitlist control will be given access to the peer support intervention on completion of the first 12-week program. A waitlist control group is an ethical alternative to no-treatment control groups when studying psychological and behavioral interventions 21. will have access to informational resources via the aTouchAway™ App and will also receive the intervention at the end of the trial.
结局指标
主要结局
Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS)
时间窗: baseline
FC mastery measured using the Pearlin Mastery Scale (PMS) (Pearlin Mastery Scale;(scores range up to 28, higher scores = higher mastery) at baseline,
Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks
时间窗: 12 week
(FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks (Pearlin Mastery Scale; (scores range up to 28, higher scores = higher mastery)
Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at 24 weeks
时间窗: 24 week
(FC) mastery measured using the Pearlin Mastery Scale (PMS) at 24 weeks (Pearlin Mastery Scale; (scores range up to 28, higher scores = higher mastery)
次要结局
- Family Caregiver Experience of the virtual peer support explored using qualitative interviews.(24 week)
- Caregiver Competency - measured using the Caregiving Competence Scale(24 week)
- Family Caregiver Burden and Stress - measured using the Zarit Burden Interview(24 week)
- Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale(24 week)
- Caregiver Competency - measured using the Caregiving Competence Scale(Baseline)
- Caregiver Competency - measured using the Caregiving Competence Scale(12 week)
- Family Caregiver Burden and Stress - measured using the Zarit Burden Interview(Baseline)
- Family Caregiver Burden and Stress - measured using the Zarit Burden Interview(12 week)
- Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale(Baseline)
- Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale(12 week)
- Family Caregiver Experience of the virtual peer support explored using qualitative interviews.(Baseline)
- Family Caregiver Experience of the virtual peer support explored using qualitative interviews.(12 week)
研究者
Reshma Amin
Associate Professor
The Hospital for Sick Children