Web-based Support to Caregivers Supporting a Person With Heart Failure - a Randomised Controlled Trial With a Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Change from baseline to 3 months in preparedness to care for a person with heart failure
研究概览
简要总结
Caregivers of people with heart failure experience a lack of support from health care in their caring role. They often want to become more involved in care, receive education and have the opportunity to share experiences with other caregivers.
Objectives and hypothesis: Our hypothesis is that an internet-based support program that is developed in collaboration with caregivers of people with heart failure will increase preparedness to care (Preparedness for Caregiving Scale). We will also evaluate the effects of the support program on the experiences of caring including positive experiences and the impact of care on health and lifestyle (Caregiver Competence Scale, Rewards of Caregiving Scale, Heart Failure-Caregiver Questionnaire) and their management of heart failure (knowledge of heart failure, support for heart failure self-care and perceived control over heart disease). We will also explore if the patients' healthcare consumption is altered when caregivers receive more support.
Method: The project is a randomized controlled study where 300 caregivers from four health care regions will be randomised to either receive a support program via 1177 care guide or to a control group waiting list who receive standard support from health care and municipalities. After the termination of the study participants in the control group will also be offered access to the support program. Data will be collected with questionnaires at baseline and after 3 and 6 months. A process evaluation with semi-structured interviews to describe the relatives' experiences of using the program with be conducted.
Relevance: Caregivers have been involved in all stages of the development of the Internet-based support program. The evaluation focuses on both the effects of the intervention and factors that affect implementation and equality. Caregiver support that is delivered through 1177 care guide enables a more equal, efficient and accessible support for caregivers.
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
- Double (Care Provider, Outcomes Assessor)
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
- •A close relative identified by the patient who cares for, supports or helps this patient with a verified heart failure diagnosis ICD codes within I42 or I50 (i.e. all types of heart failure).
排除标准
- •Relatives who are unable to carry out the data collection or participate in intervention (e.g. non-Swedish speaking, cognitive problems, severe mental illness, addiction)
- •The patient or the close relative have a serious disease with expected short survival of < 6 months.
研究组 & 干预措施
Intervention group
Study participants will receive a web-based support program
干预措施: web-based psychoeducational support (Behavioral)
Control group waiting list
Study participants in the control group waiting list will receive standard support from health care and municipalities. After study termination they will receive access to the same web-based program as the experimental group
结局指标
主要结局
Change from baseline to 3 months in preparedness to care for a person with heart failure
时间窗: Measured at baseline, after 3 months
Total score of the Preparedness for Caregiving Scale including 8 items, min score 0, max score 32, higher score indicate better preparedness
次要结局
- Change from baseline to 3 and 6 months in Caregiver Competence(Measured at baseline, after 3 and 6 months)
- Change from baseline to 3 and 6 months in Rewards of Caregiving(Measured at baseline, after 3 and 6 months)
- Perceived control over the heart disease(Measured at baseline, after 3 and 6 months)
- Change in caregiver support for heart failure self-care(Measured at baseline, after 3 and 6 months)
- Heart Failure-Caregiver burden and stress(Measured at baseline, after 3 and 6 months)
- Change from baseline to 6 months in preparedness to care for a person with heart failure(Measured at baseline, after 6 months)
- Change in knowledge about heart failure in the three subscales(Measured after 3 months)
- Change from baseline to 3 and 6 months in sleep (insomnia)(Measured at baseline, 3 and 6 months)
研究者
Anna Stroemberg
professor
Linkoeping University