NCT02526446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

2.4 years

First QC Date

August 10, 2015

Last Update Submit

April 8, 2019

Conditions

Keywords

Chinesecaregiver stressself-administered acupressure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Fatigue score

    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

    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

    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)

    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)

Study Arms (2)

Self-administered acupressure

EXPERIMENTAL

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

Wait-list control

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).

Other: wait-list control

Interventions

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).

Self-administered acupressure

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).

Wait-list control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HKSKH Lady MacLehose Center

Hong Kong, Hong Kong

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Agnes Tiwari, PhD

    School of Nursing, HKU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head of School of Nursing

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 18, 2015

Study Start

July 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations