NCT03852121

Brief Summary

This is a 8-week pilot randomized controlled trial utilizing bibliotherapy compared with usual care to investigate the feasibility and acceptability of bibliotherapy among informal caregivers of people with dementia in China, and preliminarily examine the efficacy on improving caregiving appraisal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

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

Study Start

First participant enrolled

December 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

February 4, 2019

Last Update Submit

October 13, 2020

Conditions

Keywords

caregiving appraisalbibliotherapypsychological wellbeinginformal caregiver

Outcome Measures

Primary Outcomes (1)

  • Changes in caregiving appraisal

    To be measured with the Chinese version of Caregiving Appraisal Scale (CAS). The Chinese version of CAS includes 26 items, divided into 4 subscales: caregiving burden, caregiving satisfaction, caregiving mastery, and caregiving impact. This is a 5 point Likert scale (1 = disagree a lot to 5 = agree a lot). The total score ranges from 26 to 130, with higher scores indicate more positive caregiving appraisal. The Cronbach's α for each subscale was 0.68\~0.87.

    At baseline, immediate post intervention

Secondary Outcomes (5)

  • Changes in caregiver's coping

    At baseline, immediate post intervention

  • Changes in caregiver's psychological well-being

    At baseline, immediate post intervention

  • Changes in positive aspects of caregiving

    At baseline, immediate post intervention

  • Changes in knowledge of dementia

    At baseline, immediate post intervention

  • Changes in attitude toward dementia

    At baseline, immediate post intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive bibliotherapy without withdrawing from the usual care. They will be asked to read the designated manual (consists of eight chapters) within a recommended period of time (over 8 weeks). Weekly telephone coaching will also be provided to figure out participants understanding, find out the unsolved problems and guide them for finding out the solution by themselves. An orientation will be organized before the first session. Two booster sessions will be organized during the study.

Behavioral: Bibliotherapy

Control group

NO INTERVENTION

The participants in the control group will only receive usual care provided by the community health professionals.

Interventions

BibliotherapyBEHAVIORAL

Bibliotherapy is the use of reading materials for therapeutic benefits. In this study, an evidence-based modified manual will be used as the reading material. The manual adopts the self-directed problem-solving approach to dementia caregiving, examples of how other caregivers solve the specific problem for each chapter is included in the corresponding chapter. Bibliotherapy also involves guided learning by reading written information, enabling caregivers to solve their caregiving problems "step-by-step", so telephone coach is designed to figure out participants understanding, find out the unsolved problems and guide them for finding out the solution by themselves.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caregiver who provides regular care to a person with early to moderate level of any type of medical diagnosis of dementia (PWD) for at least 5 hours per week for at least 6 months;
  • Aged 18 or above;
  • Not paid for the care provided;
  • Assist with at least one of PWD's daily activities;
  • Be able to read;
  • Can be contacted by phone.

You may not qualify if:

  • Caregivers with unstable physical or mental conditions;
  • Those with cognitive impairment;
  • Those involved in another interventional study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (14)

  • Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.

    PMID: 20637084BACKGROUND
  • Bilich LL, Deane FP, Phipps AB, Barisic M, Gould G. Effectiveness of bibliotherapy self-help for depression with varying levels of telephone helpline support. Clin Psychol Psychother. 2008 Mar-Apr;15(2):61-74. doi: 10.1002/cpp.562.

    PMID: 19115429BACKGROUND
  • Campbell LF, Smith TP. Integrating self-help books into psychotherapy. J Clin Psychol. 2003 Feb;59(2):177-86. doi: 10.1002/jclp.10140.

    PMID: 12552626BACKGROUND
  • Folkman, S., & Lazarus, R. S. (1988). Ways of coping questionnaire: Consulting Psychologists Press.

    BACKGROUND
  • Hsiao HY, Liu Z, Xu L, Huang Y, Chi I. Knowledge, Attitudes, and Clinical Practices for Patients With Dementia Among Mental Health Providers in China: City and Town Differences. Gerontol Geriatr Educ. 2016 Oct-Dec;37(4):342-358. doi: 10.1080/02701960.2014.990152. Epub 2015 Jan 27.

    PMID: 25625718BACKGROUND
  • Lawton MP, Kleban MH, Moss M, Rovine M, Glicksman A. Measuring caregiving appraisal. J Gerontol. 1989 May;44(3):P61-71. doi: 10.1093/geronj/44.3.p61.

    PMID: 2715587BACKGROUND
  • Lawton MP, Moss M, Kleban MH, Glicksman A, Rovine M. A two-factor model of caregiving appraisal and psychological well-being. J Gerontol. 1991 Jul;46(4):P181-9. doi: 10.1093/geronj/46.4.p181.

    PMID: 2071844BACKGROUND
  • Lazarus, R. S., & Folkman, S. (1986). Stress, appraisal, and coping. New York: pringer.

    BACKGROUND
  • Li, R.-H. (2014). Reliability and validity of a shorter Chinese version for Ryff's psychological well-being scale. Health Education Journal, 73(4), 446-452.

    BACKGROUND
  • Lou VW, Lau BH, Cheung KS. Positive aspects of caregiving (PAC): scale validation among Chinese dementia caregivers (CG). Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):299-306. doi: 10.1016/j.archger.2014.10.019. Epub 2014 Nov 7.

    PMID: 25488014BACKGROUND
  • Sclan SG, Reisberg B. Functional assessment staging (FAST) in Alzheimer's disease: reliability, validity, and ordinality. Int Psychogeriatr. 1992;4 Suppl 1:55-69. doi: 10.1017/s1041610292001157.

    PMID: 1504288BACKGROUND
  • Shechtman, Z. (2009). Bibliotherapy as a Method of Treatment. In Treating Child and Adolescent Aggression Through Bibliotherapy (pp. 1-17).

    BACKGROUND
  • Wang S, Cheung DSK, Leung AYM. Overview of dementia care under the three-tier long-term care system of China. Public Health Nurs. 2019 Mar;36(2):199-206. doi: 10.1111/phn.12573. Epub 2018 Dec 13.

    PMID: 30549090BACKGROUND
  • Zheng X, Chung JO, Woo BK. Exploring the Impact of a Culturally Tailored Short Film in Modifying Dementia Stigma Among Chinese Americans: A Pilot Study. Acad Psychiatry. 2016 Apr;40(2):372-4. doi: 10.1007/s40596-015-0397-7. Epub 2015 Aug 26.

    PMID: 26307362BACKGROUND

MeSH Terms

Conditions

Dementia

Interventions

Bibliotherapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Daphne Cheung, PhD

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 25, 2019

Study Start

December 1, 2018

Primary Completion

September 30, 2019

Study Completion

August 30, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations