A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 14
- 主要终点
- Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
研究概览
简要总结
The purpose of this study is to examine the efficacy of a lifestyle modification telehealth program on health-related behaviours in community-dwelling individuals living with stroke.
详细描述
Participants recruited in this study will be randomly assigned to either the Healthy Lifestyle Training Program, or Attention Control Memory Training Program.
Individuals in the Healthy Lifestyle Training Program will each receive 7 lifestyle coaching telephone-sessions (30-60 minutes) with a trained lifestyle coach over a 6 month period. Individuals in the Memory Training Program will each receive 7 memory coaching telephone sessions (30-60 minutes) with a trained memory training coach over a 6 month period. 100 evaluable subjects will be recruited (124 to accommodate for 20% dropout).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has experienced a stroke in the last 12 months
- •50 years of age or older
- •Living in the community with phone access
- •Mild to moderate stroke severity (i.e., modified Rankin Scale score ranging from 1 to 4)
- •Able to communicate in English
排除标准
- •Stroke of non-vascular origin
- •Actively engaged in formal stroke rehabilitation services
- •Uncontrolled arrhythmias
- •Significant musculoskeletal or other neurological condition
- •Severe aphasia or dysarthria
- •Not medically stable
- •Pain or co-morbidities which would preclude activity
- •Living in long-term residential care
- •Cognitive impairment, dependent in activities of daily living, and no caregiver participation
结局指标
主要结局
Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
时间窗: End of program (6 months)
The 52-item Health Promoting Lifestyle Profile II provides a composite score of lifestyle, in the areas of: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management.
次要结局
- Body composition (Body Mass Index, waist circumference)(End of program (6 months), and 6 months after the program ends (12 months from baseline))
- Dietary behavior (26 items SmartDiet Questionnaire)(End of program (6 months), and 6 months after the program ends (12 months from baseline))
- Depressive symptoms (20-item Centre for Epidemiological Studies-Depression [CES-D] Scale)(End of program (6 months), and 6 months after the program ends (12 months from baseline))
- Daily walking physical activity(End of program (6 months), and 6 months after the program ends (12 months from baseline))
- Medication adherence (8-item Morisky Medication Adherence Scale)(End of program (6 months), and 6 months after the program ends (12 months from baseline))
- Health-related quality of life (SF-36)(End of program (6 months), and 6 months after the program ends (12 months from baseline))
- Cognition (Montreal Cognitive Assessment [MoCA])(End of program (6 months), and 6 months after the program ends (12 months from baseline))
- Cardiovascular risk factors (resting blood pressure, lipid, and glucose profiles, C-Reactive Protein, Homocysteine).(End of program (6 months), and 6 months after the program ends (12 months from baseline))
- Health and Social Services Utilization (Health and Social Service Utilization Inventory)(End of program (6 months), and 6 months after the program ends (12 months from baseline))
- Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)(6 months after the program ends (12 months from baseline))
研究者
Janice Eng
Principal Investigator
University of British Columbia