Self-administered Acupressure for Symptom Management of Caregiver Stress

April 8, 2019 updated by: Professor Agnes Tiwari, The University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • HKSKH Lady MacLehose Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-administered acupressure
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

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).
Other: Wait-list control
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caregiver stress
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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)
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Agnes Tiwari, PhD, School of Nursing, HKU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 16, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UW 15-367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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