跳至主要内容
临床试验/NCT03023332
NCT03023332已完成不适用

Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers

Case Western Reserve University2 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2017年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
310
试验地点
2
主要终点
Change in Caregiver Health - Health Risks

研究概览

简要总结

How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with bipolar disorder? Caregivers will be randomized to: 1) a control group (no intervention); 2) education (usual care); 3) self-management intervention based on need (SM-need); or 4) self-management intervention of their preference (SM-preference).

详细描述

The study has two aims: The primary aim (A1) is to examine differences across the four groups (control, usual care, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. We hypothesize that the caregivers who receive a self-management intervention based on need (SM-need) or preference (SM-preference) will have better health outcomes than those in the usual care or control groups.

Secondary aims are to: A2) explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/ contextual factors that are associated with their needs and preferences for the self-management interventions.

All caregivers will complete assessment measures and measures of health risks, and physical and mental health at baseline (T1), 6 months (T2) and 12 months (T3). Caregivers will randomly assigned to one of four groups. The control group will receive no intervention. The usual care group will receive bipolar education. The SM-need group will receive a self-management intervention tailored to meet their need for bipolar education, biofeedback training, or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the three self-management intervention according to their personal preference.

All three self-management interventions (bipolar education, biofeedback training, resourcefulness training) are delivered over four weeks (between T1 and T2). Caregivers may use the one SM intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. The bipolar education and resourcefulness training interventions will be delivered initially using an iPad. These interventions involve providing educational information about bipolar disorder or teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of use of a hand-held device that shows the participant their changes in heart rate based on changes in their breathing pattern (as they relax); caregivers who need or prefer the biofeedback will be given a device to use for 28 days. All study participants receiving the intervention will also be asked to keep a journal to record their experience with the intervention.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English-speaking
  • At least 18 years old
  • Have a family member with bipolar disorder
  • Have cared/supported them for at least the last 6 months in the last year
  • Be capable of performing the informed consent and participate in interventions

排除标准

  • Does not have family member with bipolar disorder
  • Has not cared for family member for at least 6 months in the last year
  • Knowledge of another family member in the same household enrolled in the study
  • Is pregnant
  • Has a pacemaker
  • Lives outside of the study area (Cuyahoga, Lake, Geauga, Portage, Summit, Medina, and Lorain counties)

结局指标

主要结局

Change in Caregiver Health - Health Risks

时间窗: 12 months

Health risks were measured using the Change in Health Risk Behavior Scale. The scale consists of 9 items measured on a 3-point scale, Scores range 9-27; higher score indicates greater risk

Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)

时间窗: 12 months

Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) scale. 5 items - physical health; 5 items - mental health; 5-point scale; Scores range 0-40; higher scores indicate better health.

次要结局

  • Change in Resourcefulness(12 months)
  • Change in Bipolar Knowledge Assessment Scale(12 months)
  • Change in Heart Rate Variability(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaclene A. Zauszniewski

Principal Investigator

Case Western Reserve University

研究点 (2)

Loading locations...

相似试验