The Effects and Mediating Mechanism of the Existential Cognitive Intervention to Enhance Positive Aspect of Caregiving (EXCITE-PAC) in a Dementia Context: A Sequential Mixed Method Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- The Positive Aspect of Caregiving Instrument
研究概览
简要总结
Research evidence is emerging on the co-existence of a positive caregiving experience in the physically and psychosocially taxing dementia care context, but little attention has been paid to promoting the positive aspects of caregiving (PAC) among family carers.
We adopt the paradigm of existential positive psychology, integrating cognitive behavioural theory, construal level theory, and Antonovsky's theory of salutogenesis to develop an existential-cognitive intervention to enhance positive aspects of caregiving (EXCITE-PAC), and thereby improve the health outcomes of family carers of people living with dementia (PLwD).
A pilot mixed-method study comprising a randomised controlled trial and a post-trial qualitative interview is proposed to evaluate the effects of EXCITE-PAC on carers' health and to examine whether any such effects are mediated through changes in PAC. Post-trial interviews with carers will further elucidate their experiences of the intervention and their perceptions of its impact.
Overall aim & objectives
This sequential mixed-method study aims to:
i) evaluate the effects of the 12-week EXCITE-PAC programme on PAC (primary outcome), Health-related quality of life (HRQoL), depression, caregiving self-efficacy and meaning-making among the family carers of PLwD; ii) explore whether the health benefits of EXCITE-PAC, if any, are mediated through improved PAC at the 36-week (i.e., about 6 months) follow-up endpoints; and iii) explore carers' perceptions of the benefits, limitations and acceptability of the EXCITE-PAC programme.
详细描述
Research evidence is emerging on the co-existence of a positive caregiving experience in the physically and psychosocially taxing dementia care context, but little attention has been paid to promoting the positive aspects of caregiving (PAC) among family carers.
We adopt the paradigm of existential positive psychology, integrating cognitive behavioural theory, construal level theory, and Antonovsky's theory of salutogenesis to develop an existential-cognitive intervention to enhance positive aspects of caregiving (EXCITE-PAC), and thereby improve the health outcomes of family carers of people living with dementia (PLwD).
Objectives:
i) To evaluate the effects of the existential-cognitive intervention to enhance the positive aspects of caregiving (EXCITE-PAC) on PAC and the health outcomes of family carers of persons living with dementia (PLwD).
ii) To evaluate whether the positive health effects of EXCITE-PAC, if any, are mediated through a change in PAC.
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
- Single (Outcomes Assessor)
盲法说明
The data collectors for the post-test will be blinded from the group status and participants will not be informed on the group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •family carers of Chinese PLwDs diagnosed at least six months previously
- •caregiving for ≥ 4 hours/day
- •Chinese-speaking
- •have a mobile device to access virtual meeting via Go-To-Meeting or Zoom
- •consent to participate
排除标准
- 未提供
研究组 & 干预措施
Usual care
Usual care will be provided to the control group which mainly covers the social activities offered by the affiliated center. The participants are requested not to join any activities relating to cognitive training or auditory training before the post-test data collection.
干预措施: Usual care (Other)
Experimental : EXCITE-PAC program
The EXCITE-PAC program is an overall 12-week training and comprises of three phases as follows:
Face-to-face home visit to establish narrative-based caregiver biographies. Group-based virtual meetings with video-guided self-distancing cognitive reappraisal to enhance emotional regulation and meaning-making. The goal-oriented empowerment approach will be used to facilitate carers' use of reframing and refocusing techniques in the day-to-day caregiving proces.
Telephone follow-ups will be made to continue supporting goal attainment.
干预措施: Existential-cognitive intervention to enhance PAC (Behavioral)
结局指标
主要结局
The Positive Aspect of Caregiving Instrument
时间窗: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
To evaluate self-affirmation and outlook on life. It is a 5-point Likert scale, with higher total scores (ranging from 11-55) indicating a more positive perception of the caregiving role.
The Caregiving Self-Efficacy Scale
时间窗: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
To evaluate self-efficacy of carers in managing disturbing behaviour, controlling upsetting thoughts and obtaining a respite in caring for of the PLwD, with higher scores representing greater self-confidence. It is a 15-item tool used to assess caregivers' confidence in managing caregiving situations, rated on a 0-100 scale. Higher score indicate stronger self-efficacy.
The Meaning-Focused Coping Scale
时间窗: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
To evaluate meaning-focused coping, including changes in situational and global beliefs, goals, meaning making, long-term prevention strategies, rational resource use, acceptance and heuristic thinking. It is a 26-items tool using a 7-point Likert scale, higher scores indicating a higher level of meaning-focused coping.
The 10-item Centre of Epidemiological Studies Depression Scale
时间窗: Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).
To evaluate affective symptoms reflecting depression on an ascending 4-point scale of increasing severity.
次要结局
- The Medical Outcomes Study Short Form Health Survey(Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).)
- Positive Affect Index(Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).)
- The Intrinsic Motivations to Care(Baseline (T0), Up to 12 weeks (T1), up to 24 weeks (T2), up to 36 weeks (T3).)
研究者
Prof. Yu, Doris Sau Fung
Proferssor
The University of Hong Kong