Effects of a Psycho-educational Intervention for Family Caregivers in Palliative Care
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 270
- 主要终点
- TRIG
研究概览
简要总结
Health care systems are increasingly using outpatient care for patients with advanced cancer disease with complex needs, limited life expectancy, and need for palliative care. Family caregivers are centrally important, but are often insufficiently prepared for the caregiving role, and experience psychological distress and physical symptoms. We hypothesize that a psycho-educational intervention during ongoing palliative care will support family caregivers' wellbeing and decrease negative consequences of caregiving.
The intervention, which has been developed in steps through a series of studies based on theoretical, methodological, and empirical work, was delivered in a group format 2013-2014. Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each meeting had a specific topic presented by a member of the palliative care team (physician, nurse, and social worker). The meetings addressed multi-dimensional issues in dialogue with the participants.
The overall aim of this ongoing project is to investigate short and long-term effects of the intervention delivered by health professionals at ten specialized palliative home care units. Multiple methods are now being used, including a randomized controlled trial (RCT). In total, 270 family caregivers have been requested to answer a questionnaire at four time points: at baseline, upon completion and again 2 months after completion of the intervention, and 6 months after the patient's death. The primary outcome variable is preparedness for caregiving, and the secondary outcome variables cover aspects of wellbeing including competence and reward, caregiver burden, health, anxiety and depressive symptoms, and grief. These data will be complemented with interviews.
The project has the potential to contribute knowledge about the development of support for family caregivers, not only in specialized palliative care but also in other contexts such as elderly care and general home care services.
详细描述
Specific aims are to:
I) Determine the effects of the intervention upon completion, in relation to preparedness for caregiving, competence for caregiving, reward of II) Determine the effects of the intervention in a 2-month follow-up, in relation to preparedness for caregiving, competence for caregiving, reward of caregiving, health, anxiety, depressive symptoms, and caregiver burden III) Determine the effects of the intervention 6-month after the death of the patient, in relation to the family caregiver's health, anxiety, depressive symptoms and grief IV) Identify characteristics of family caregivers who do not respond to the intervention and describe support needs for these individuals V) Investigate associations between preparedness for caregiving (main outcome) and competence for caregiving, reward of caregiving, health, anxiety, depressive symptoms, caregiver burden and grief (secondary outcomes) VI) Evaluate intervention processes from the perspective of family caregivers and health care professionals VII) Investigate the influences of the caregiver intervention, for the patients with advanced cancer disease
A psycho-educational intervention was developed based on the theoretical framework of Andershed and Ternestedt relating to the principal support needs of family caregivers. The framework describes family caregivers' involvement in caregiving, and focuses on knowing, being and doing. Knowing is considered crucial for family caregivers, and is connected to an awareness of the nature of the caregiving role: knowing what to expect and what to do. Being is related to the management of one's own emotions and those of one's relative. Doing covers the practical care acts including a range of activities. It is assumed that insight will increase family caregivers' possibilities for making choices and for their involvement in caregiving.
The aim of the intervention is to increase family caregivers' feelings of preparedness for caregiving, to support their wellbeing, and to decrease negative consequences associated with caregiving. Preparedness refers to how ready family caregivers perceive they are for the tasks and demands of the caregiving role, such as providing physical care, providing emotional support and dealing with the stress of caregiving. It is suggested that preparedness could support wellbeing and protect against negative consequences in relation to caregiving. The intervention is delivered as a programme in a group format and its components, design, acceptability, feasibility and potential effects have been confirmed in a series of previous studies. During the development process, slight modifications concerning the content and structure have been done based on participant experiences.
Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each meeting had a specific topic presented by a health care professional of the palliative care team (physician, nurse and social worker). The meetings addressed multi-dimensional issues in dialogue with the participants. A nurse acted as group leader and participated in all meetings. The intervention included both supportive and educational components. Each meeting began with a presentation based on a specific topic (palliative care, practical care and emotional reactions). This was followed by reflection and conversation, and finally a relaxation exercise
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
- None
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
- •Being family caregiver to a person in specialized palliative home care,
- •Over the age of 18, and
- •Able to read and understand Swedish.
排除标准
- 未提供
结局指标
主要结局
TRIG
时间窗: 6 months after the patient's death
TRIG measures complicated grief on a 5 Point likert type scale ranging from 1 (Completely true) to 5 (Completely false).
Change in the PCS 5 weeks and 13 weeks after baseline
时间窗: Baseline, 5 weeks, 13 weeks
The PCS is designed to measure caregivers' perceived readiness to provide care in real time. It consists of eight items answered on a five-point Likert-type response scale ranging from 'not at all prepared' (0) to 'very well prepared' (4) with a total score ranging from 0-32.
次要结局
未报告次要终点
研究者
Anette Henriksson
PhD, lecturer in Palliative Care
Ersta Sköndal University College