The construction of supporting model for family caregivers of people with dementia - a preliminary study of barriers and needs

ISRCTN ISRCTN13505830
DOI https://doi.org/10.1186/ISRCTN13505830
Secondary identifying numbers TRLS-D17-00988
Submission date
15/12/2017
Registration date
18/01/2018
Last edited
02/04/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Dementia is a broad category of brain diseases that cause a gradual decrease in the ability to think and remember. Due to the rapid increase of the aging population, there is a fast growing number of dementia patients in Taiwan. Many dementia patients are cared for at home, but there are few studies about the needs and barriers for family caregivers supporting people with dementia. The aim of this study is to explore the barriers and construct a supporting model in terms of needs for family caregivers of people with dementia.

Who can participate?
Group 1: primary family caregivers
Group 2: people diagnosed with dementia including Alzheimer’s disease, vascular dementia and other types of dementia
Group 3: healthcare professionals including physicians, nurses, social workers and paid carers who are familiar with the disease and patients with dementia

What does the study involve?
The study divides into two phases. In phase I, participants are recruited from the outpatients of Neurology and Geriatrics Departments of a teaching hospital in Taichung to participate in interviews and to use a caring diary. At phase II, participants are selected from the above groups to participate in questionnaires. This study examines the barriers and needs of family caregivers of people with dementia in five areas: (1) knowledge of dementia and caring skills to cope with problem behaviours; (2) medication and comorbidity management; (3) family relationship and psychological support, (4) resources and benefits and (5) education and skills training. In the end, a supporting model of needs for family caregivers is constructed to provide healthcare professionals and family caregivers with more concise information and insights about the problems.

What are the possible benefits and risks of participating?
The healthcare professionals and the family caregivers may gain a deeper understanding of the barriers and needs of caring for a family with dementia. The risks of participating may result from recalling negative memories or experiences of caregiving among the family caregivers during the interviews and writing the care diary. In this situation, participants are advised to leave the study and are directed to suitable counselling if they wish.

Where is the study run from?
China Medical University Hospital (China)

When is the study starting and how long is it expected to run for?
December 2017 to May 2018

Who is funding the study?
China Medical University Hospital (China)

Who is the main contact?
Dr Chia-Ming Yen
ayen1001@gmail.com

Contact information

Dr Chia-Ming Yen
Public

Medical Center of Aging Research, China Medical University Hospital
Taichung
40402
Taiwan

Phone +886 (0)953026819
Email ayen1001@gmail.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe construction of supporting model for family caregivers of people with dementia - a preliminary study of barriers and needs
Study objectivesThere are 2 study hypotheses: firstly it is assumed that family caregivers of people with dementia suffer from barriers. Second, the needs and support from family caregivers of people with dementia are uncleared by healthcare professionals.
Ethics approval(s)Research Ethics Committee, China Medical University & Hospital, 05/12/2017, ref: CMUH-REC1-142
Health condition(s) or problem(s) studiedDementia
InterventionThe recruitment of participants is randomized in this study. There are two Phases of participant recruitment:

In phase I, healthcare professionals, for example, physicians, will be selected from the list of outpatient’s timetable from Departments of Neurology, Psychiatry or Family Science in China Medical University Hospital. Other healthcare professionals will be then recruited by using snowball sampling from the same Hospital afterwards. Patients and family caregivers will be recruited through the introduction of physicians. An in-depth interview and caring diary will be adopted.

The participants are divided into three groups, Group 1 and 2 contain 10 participants respectively. Group 3 includes 18 participants. Participants from Group 1 are the primary family caregivers regardless of age and gender; Group 2 contains people who are diagnosed with dementia including Alzheimer’s disease, vascular dementia and other types of dementia and regardless the stage of disease process. That is he or she is in his/her early, mild and server stages of dementia. Group 3 contains of 18 healthcare professionals including physicians, nurses, social workers and paid carers who are familiar with the disease and patients of dementia.

In phase II, 10 participants will be selected from the above groups to participate in Delphi questionnaires.

This study will systematically examine the barriers and needs of family caregivers of people with dementia in five domains:
1. Knowledge of dementia and caring skills to cope with problem behaviours
2. Medication and comorbidity management
3. Family relationship and psychological supports
4. Resources and benefits
5. Education and skills training
In the end, the supporting model of needs for family caregivers will be constructed which will be expected to provide healthcare professionals and family caregivers more concise information and insights about the problems.
Intervention typeOther
Primary outcome measureinterview results; qualitative interview results will be transcribed into text then the text will be analyzed. Thematic analysis will be used to analyze the text. Themes and subthemes will be cited from the text.
Secondary outcome measuresDelphi questionnaire results; the design of the Delphi questionnaire will be based on literature review and the themes and subthemes cited from interviews.
Overall study start date01/12/2017
Completion date31/12/2018

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants38
Key inclusion criteriaThe participants are divided into three groups:
Group 1 contains the primary family caregivers who live with the care recipient, regardless of age and gender
Group 2 contains people who are diagnosed with dementia. To have a complete picture from patients of dementia in terms of needs and supports in this study, people with any age and sex with a diagnosis of dementia (Alzheimer’s disease, vascular dementia or mixed Alzheimer’s and vascular dementia, or other types of dementia) who live in the community (excluding people in institutions receiving 24 hours of care). Also people at different stage of disease processes (people who are still able to express his/her views mainly) will be included
Group 3 contains healthcare professionals including neurologic or geriatric physicians, nurses, clinical psychologist, occupational therapist, social workers and paid carers
Key exclusion criteria1. Healthcare professional who never works with dementia patients
2. Primary family caregiver who does not live with the care recipient
Date of first enrolment18/12/2017
Date of final enrolment30/06/2018

Locations

Countries of recruitment

  • Taiwan

Study participating centre

Medical Center of Aging Research, China Medical University Hospital
40402
Taiwan

Sponsor information

Medical Center of Aging Research, China Medical University Hospital
Hospital/treatment centre

Cancer Building, 120, Wu-Yi Street
Taichung
40402
Taiwan

Phone +886 (0)953026819
Email ayen1001@gmail.com
ROR logo "ROR" https://ror.org/00v408z34

Funders

Funder type

Hospital/treatment centre

China Medical University Hospital
Government organisation / Local government
Alternative name(s)
CMUH
Location
Taiwan

Results and Publications

Intention to publish date30/06/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe protocol is being submitted to Trials (journal) at the moment. A planned publication in a high-impact peer reviewed journal will be considered after the completion of data collection and final report of the project.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Chia-Ming Yen (ayen1001@gmail.com). The data will be possibly available around one year after the trial ends on 30/06/2018.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 16/01/2019 02/04/2020 Yes No

Editorial Notes

02/04/2020: Publication reference added.
08/08/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 31/05/2018 to 31/12/2018
2. The recruitment end date has been changed from 31/03/2018 to 30/06/2018
18/01/2018: Internal review.