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

NCT ID: NCT03852121

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-08-30

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.

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bibliotherapy

Intervention Type: BEHAVIORAL

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Daphne Cheung

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daphne Cheung, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

Locations

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

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Provided Documents

Document Type: Informed Consent Form

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Other Identifiers

HSEARS20181120001

Identifier Type: -

Identifier Source: org_study_id