Self-administered Acupressure for Symptom Management of Caregiver Stress

Study Overview
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Brief Summary
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This proposed study is to evaluate the effectiveness of a self-administered acupressure intervention on caregiver stress and associated distress symptoms of fatigue, insomnia and depression in Chinese family caregivers of an elderly family member.

Detailed Description
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Taking care of an elderly family member can be stressful and family caregivers are at risk for emotional, mental and physical health problems arising from caregiver stress. Although a variety of psychosocial and pharmacological strategies have been developed to reduce caregiver stress, the efficacy in mitigating caregiver distress is modest. Acupressure, a non-invasive technique of Traditional Chinese Medicine (TCM) by applying pressure on acupoints, has been successfully used for management of multiple symptoms without adverse effects. Thus, this study using a randomized, wait-list controlled trial is to evaluate the effectiveness of self-administered acupressure intervention on caregiver stress and associated distress symptoms of fatigue, insomnia or depression. A total of 200 Chinese family caregivers with caregiver stress and stress related symptoms of fatigue, insomnia or depression will be recruited from a community setting in Hong Kong and randomized to receive either a self-administered acupressure intervention or wait-list condition. The self-administered acupressure intervention will comprise (i) 5-hr individual learning and training session in the first 2 weeks, (ii) 2-hr home-visit reinforcement during 3rd and 4th week, and (iii) a total of 21-hr self-practice at home over 6 weeks. It is hypothesized that the family caregivers in the intervention group will have, upon completion of the program, lower levels of caregiver stress, lower scores of fatigue, insomnia, and depression with improved health-related quality of life as compared with that in the wait-list control group.

Official Title
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A Randomized, Wait-list Controlled Trial of Self-administered Acupressure for Symptom Management Among Chinese Family Caregivers With Caregiver Stress

Conditions
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Stress

Intervention / Treatment
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* Behavioral: Self-administered acupressure
* Other: wait-list control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese woman or man, 21 years of age or older, able to communicate in Cantonese or Putonghua, Primary caregiver of an elderly family member aged ≥ 65 years, Providing unpaid care to the care recipient at no less than 14 hours per week, Primarily responsible for making day-to-day decisions and providing assistance to the care recipient in tasks relating to activities of daily living (e.g. bathing, dressing, toileting etc.) and/or instrumental activities of daily living (e.g. housework, grocery shopping, preparing meals, managing medications etc.), and Screened positive for caregiver stress (a summed score of ≥ 25 as measured by the Caregiver Burden Inventory), with symptoms of fatigue (a mean score of ≥ 4 as measured by the Piper Fatigue Scale), insomnia (a global score of > 5 as measured by the Pittsburgh Sleep Quality Index), OR depression (a total score of ≥ 10 as measured by the Patient Health Exclusion Criteria: Cognitive impairment (a Mini Mental State Examination (MMSE) score of ≤ 23), or Major chronic illness (e.g. cancer) or currently taking any medications (e.g. opiates) that may prevent them from performing the intervention, or Participated in intervention studies involving acupressure or acupuncture previously.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-administered acupressure<br>The intervention consists of a total of 28 hours over a period of 8 weeks. It comprises of individual learning and practice, self-practice at home, and home follow-up. | Behavioral: Self-administered acupressure<br>* The intervention consists of a total of 28 hours over a period of 8 weeks: i) Individual learning and practice: The training session will be one-on-one provided twice a week for two consecutive weeks (5 hours) in the participant's home. ii) Self-practice at home: From 3rd to 8th week, participant will engage in self-administered acupressure at home for 15 minutes twice a day for 6 weeks (21 hours). iii) Home follow-up: During the 3rd and 4th week (i.e. after the 2-week training session), a 1-hour home visit will be conducted for reinforcement of learning and self-practice by the same team of trainers once a week for 2 weeks (2 hours).<br>|
| Other: Wait-list control<br>The control group will receive a wait-list control condition (the same self-administered acupressure intervention but after the intervention group has completed the treatment condition). | Other: wait-list control<br>* The control group will receive a wait-list control condition (the same self-administered acupressure intervention but after the intervention group has completed the treatment condition).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in caregiver stress | Score on measure of caregiver stress by Chinese version of the Caregiver Burden Inventory (C-CBI) | Baseline (T0, on entry to study before intervention), (ii) post-training (T1, 2-week later on completion of the group training, (iii) post-intervention (T2, 6-week later on completion intervention, and (iv) follow-up (T3, 4-week post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue score | Score on measure of Fatigue by Chinese Piper Fatigue Scale (C-PFS) | Baseline (T0, on entry to study before intervention), (ii) post-training (T1, 2-week later on completion of the group training, (iii) post-intervention (T2, 6-week later on completion intervention, and (iv) follow-up (T3, 4-week post-intervention) | 
| Insomnia score | Score on measure of Insomnia by Chinese Pittsburgh Sleep Quality Index (C-PSQI) | Baseline (T0, on entry to study before intervention), (ii) post-training (T1, 2-week later on completion of the group training, (iii) post-intervention (T2, 6-week later on completion intervention, and (iv) follow-up (T3, 4-week post-intervention) | 
| Depression score | Score on measure of Depression by Chinese Patient Health Questionnaire (C-PHQ); | Baseline (T0, on entry to study before intervention), (ii) post-training (T1, 2-week later on completion of the group training, (iii) post-intervention (T2, 6-week later on completion intervention, and (iv) follow-up (T3, 4-week post-intervention) | 
| Caregiver's quality of life (QoL) | Score on measure of Quality of Life by Chinese SF-12 version 2 Health Survey (SF-12v2) | Baseline (T0, on entry to study before intervention), (ii) post-training (T1, 2-week later on completion of the group training, (iii) post-intervention (T2, 6-week later on completion intervention, and (iv) follow-up (T3, 4-week post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese, caregiver stress, self-administered acupressure