Self-administered Acupressure for Symptom Management of Caregiver Stress

NCT ID: NCT02526446

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-12-31

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.

Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Self-administered acupressure

Intervention Type BEHAVIORAL

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).

Group Type OTHER

wait-list control

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type BEHAVIORAL

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).

Intervention Type OTHER

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Agnes Tiwari

Professor and Head of School of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agnes Tiwari, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, HKU

Locations

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HKSKH Lady MacLehose Center

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Tiwari A, Fong DY, Yuen KH, Yuk H, Pang P, Humphreys J, Bullock L. Effect of an advocacy intervention on mental health in Chinese women survivors of intimate partner violence: a randomized controlled trial. JAMA. 2010 Aug 4;304(5):536-43. doi: 10.1001/jama.2010.1052.

Reference Type RESULT
PMID: 20682933 (View on PubMed)

Zhang Y, Shen CL, Peck K, Brismee JM, Doctolero S, Lo DF, Lim Y, Lao L. Training Self-Administered Acupressure Exercise among Postmenopausal Women with Osteoarthritic Knee Pain: A Feasibility Study and Lessons Learned. Evid Based Complement Alternat Med. 2012;2012:570431. doi: 10.1155/2012/570431. Epub 2012 Oct 23.

Reference Type RESULT
PMID: 23193423 (View on PubMed)

Tiwari A, Chan CL, Ho RT, Tsao GS, Deng W, Hong AW, Fong DY, Fung HY, Pang EP, Cheung DS, Ma JL. Effect of a qigong intervention program on telomerase activity and psychological stress in abused Chinese women: a randomized, wait-list controlled trial. BMC Complement Altern Med. 2014 Aug 15;14:300. doi: 10.1186/1472-6882-14-300.

Reference Type RESULT
PMID: 25127878 (View on PubMed)

Yeung WF, Chung KF, Poon MM, Ho FY, Zhang SP, Zhang ZJ, Ziea ET, Wong VT. Acupressure, reflexology, and auricular acupressure for insomnia: a systematic review of randomized controlled trials. Sleep Med. 2012 Sep;13(8):971-84. doi: 10.1016/j.sleep.2012.06.003. Epub 2012 Jul 25.

Reference Type RESULT
PMID: 22841034 (View on PubMed)

Wang XM, Walitt B, Saligan L, Tiwari AF, Cheung CW, Zhang ZJ. Chemobrain: a critical review and causal hypothesis of link between cytokines and epigenetic reprogramming associated with chemotherapy. Cytokine. 2015 Mar;72(1):86-96. doi: 10.1016/j.cyto.2014.12.006. Epub 2015 Jan 5.

Reference Type RESULT
PMID: 25573802 (View on PubMed)

Cheung DST, Tiwari A, Yeung WF, Yu DSF, So MKP, Chau PH, Wang XM, Lum TYS, Yuk Fung HYK, Ng BYM, Zhang ZJ, Lao L. Self-Administered Acupressure for Caregivers of Older Family Members: A Randomized Controlled Trial. J Am Geriatr Soc. 2020 Jun;68(6):1193-1201. doi: 10.1111/jgs.16357. Epub 2020 Feb 25.

Reference Type DERIVED
PMID: 32096884 (View on PubMed)

Tiwari A, Lao L, Wang AX, Cheung DS, So MK, Yu DS, Lum TY, Yuk Fung HY, Yeung JW, Zhang ZJ. Self-administered acupressure for symptom management among Chinese family caregivers with caregiver stress: a randomized, wait-list controlled trial. BMC Complement Altern Med. 2016 Oct 28;16(1):424. doi: 10.1186/s12906-016-1409-1.

Reference Type DERIVED
PMID: 27793197 (View on PubMed)

Other Identifiers

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UW 15-367

Identifier Type: -

Identifier Source: org_study_id

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