Bibliotherapy for Improving Caregiving Appraisal Among Informal Caregivers of People With Dementia: A Pilot RCT

October 13, 2020 updated by: Dr Daphne Cheung, The Hong Kong Polytechnic University

Bibliotherapy for Improving Caregiving Appraisal Among Informal Caregivers of People With Dementia: A Pilot Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: China is one of the countries with the highest number of people with dementia (PWD), while over 90% of PWD are cared by informal caregivers in the community. Informal caregivers are found to have higher level of stress, and lower level of well-being than non-caregivers. However, positive outcomes of caregiving have also been noted. Caregiving appraisal is caregivers' cognitive evaluation of potential caregiving stressors and the efficacy of their coping efforts related to caregiving experience. Based on Lawton's Caregiving Appraisal and Psychological Well-being Model, caregiving appraisal is an important factor that leads to the positive or negative well-being outcomes of caregivers. Addressing the caregiving appraisal of informal caregiver may be able to help in promoting the caregiver well-being and delay premature institutionalization. Intervention for improving dementia caregiving appraisal is still scarce, especially in China. Bibliotherapy is the process of learning from high-quality written materials for therapeutic benefits, it has been proved to be effective in improving caregiving appraisal of informal caregivers of people with psychosis and depression, its effect on dementia caregivers is unsure.

Objectives: There are two research objectives in this study: (1) To determine the feasibility and acceptability of the evidence-based bibliotherapy protocol among informal caregivers of PWD in China. (2) To preliminarily explore the efficacy of bibliotherapy on improving caregiving appraisal.

Methods:

Sixty participants will be recruited from Zhengzhou, China, and will be randomly allocated to either the intervention group or usual care group. The feasibility of the intervention will be explored in terms of the ease of participant recruitment, attendance rate and the attrition rate. The acceptability will be explored by interviews of participants in the intervention group at post-intervention. The Chinese version of Caregiving Appraisal Scale, the Chinese version of Ways of Coping Questionnaire, the Chinese version of Positive Aspects of Caregiving Scale, the Chinese version of Ryff's Psychological Well-being Scale, Alzheimer's Disease Knowledge Scale and Dementia Attitude Scale will be used to measure caregiving appraisal, coping, positive aspects of caregiving, psychological well-being, knowledge of dementia and attitude toward dementia of informal caregivers of PWD respectively. Descriptive statistics, Chi-square test, Mann Whitney U test, and independent t-test will be used to describe the participants' characteristics and compare the difference between groups at baseline. GEE will be used to examine the intervention efficacy.

Study Type

Interventional

Enrollment (Actual)

60

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
        • School of Nursing, The Hong Kong Polytechnic University

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
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
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.
NO_INTERVENTION: Control group
The participants in the control group will only receive usual care provided by the community health professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in caregiving appraisal
Time Frame: At baseline, immediate post intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in caregiver's coping
Time Frame: At baseline, immediate post intervention
To be measured with the Chinese version of Ways of Coping Questionnaire. This questionnaire includes 20 items, divided into 2 subscales: the active coping subscale and the passive coping subscale. The passive coping subcale was recoded. The total score ranges from 0-60, higher score indicates more positive coping. It is a 4 point Likert scale (0 = never to 3 = often). The Cronbach's α was 0.90, αs for the two subscales were 0.89 and 0.78.
At baseline, immediate post intervention
Changes in caregiver's psychological well-being
Time Frame: At baseline, immediate post intervention
To be measured with the shorter Chinese version for Ryff's Psychological Well-being Scale. This scale includes 18 items, and is divided into 6 subscales: positive relations with others, autonomy, environmental mastery, personal growth, purpose in life and self-acceptance. This scale is a Likert 6 point scale, with 1 = strongly disagree to 6 = totally agree, higher scores indicate better psychological well-being. The total score ranges from 6-108. The scale has been tested in middle-aged and older people, the Cronbach's α was 0.92 for the total scale, and at least 0.60 for each subscale.
At baseline, immediate post intervention
Changes in positive aspects of caregiving
Time Frame: At baseline, immediate post intervention
To be measured with the Chinese version of Positive Aspects of Caregiving (C-PAC) Scale. It is a Likert 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) regarding the extent to which providing care to their relatives with dementia had enabled them "feel important", "feel appreciated" etc. The scale has 11 items, divided into two subscales: enriching life and affirming self. The total score ranges from 5-55. The Cronbach's α was 0.89 for the total scale, the αs for enriching life and affirming self subscales were 0.85 and 0.84 respectively.
At baseline, immediate post intervention
Changes in knowledge of dementia
Time Frame: At baseline, immediate post intervention
To be measured with the Chinese version of Alzheimer's Disease Knowledge Scale. This scale has 30 items, with "true" or "false" choices for each item. The total score ranges from 0-30. Higher score indicates more knowledgement about dementia. The Cronbach's a was 0.785.
At baseline, immediate post intervention
Changes in attitude toward dementia
Time Frame: At baseline, immediate post intervention
To be measured with the Chinese version of Dementia Attitude Scale. This is a 20-item Likert 7 point scale (1=strongly disagree, 7=strongly agree). The total score ranges from 20-140, higher scores indicate more positive attitude toward dementia. The Cronbach's α was 0.818.
At baseline, immediate post intervention

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

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)

December 1, 2018

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

August 30, 2020

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (ACTUAL)

February 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20181120001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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