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Self-administered Acupressure for Symptom Management of Caregiver Stress

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ClinicalTrials.gov Identifier: NCT02526446
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Agnes Tiwari, The University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Behavioral: Self-administered acupressure Other: wait-list control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized, Wait-list Controlled Trial of Self-administered Acupressure for Symptom Management Among Chinese Family Caregivers With Caregiver Stress
Actual Study Start Date : July 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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).


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).




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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);

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526446


Locations
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Hong Kong
HKSKH Lady MacLehose Center
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Agnes Tiwari, PhD School of Nursing, HKU
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Agnes Tiwari, Professor and Head of School of Nursing, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02526446    
Other Study ID Numbers: UW 15-367
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Keywords provided by Professor Agnes Tiwari, The University of Hong Kong:
Chinese
caregiver stress
self-administered acupressure