Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Dr Chia-Ming Yen
ORCID ID
Contact details
Medical Center of Aging Research
China Medical University Hospital
Taichung
40402
Taiwan
+886 (0)953026819
ayen1001@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TRLS-D17-00988
Study information
Scientific title
The construction of supporting model for family caregivers of people with dementia - a preliminary study of barriers and needs
Acronym
Study hypothesis
There 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
Research Ethics Committee, China Medical University & Hospital, 05/12/2017, ref: CMUH-REC1-142
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Dementia
Intervention
The 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 type
Other
Phase
Drug names
Primary outcome measure
interview 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 measures
Delphi questionnaire results; the design of the Delphi questionnaire will be based on literature review and the themes and subthemes cited from interviews.
Overall trial start date
01/12/2017
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The 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
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
38
Participant exclusion criteria
1. Healthcare professional who never works with dementia patients
2. Primary family caregiver who does not live with the care recipient
Recruitment start date
18/12/2017
Recruitment end date
30/06/2018
Locations
Countries of recruitment
Taiwan
Trial participating centre
Medical Center of Aging Research, China Medical University Hospital
40402
Taiwan
Sponsor information
Organisation
Medical Center of Aging Research, China Medical University Hospital
Sponsor details
Cancer Building
120
Wu-Yi Street
Taichung
40402
Taiwan
+886 (0)953026819
ayen1001@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
China Medical University Hospital
Alternative name(s)
CMUH
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Taiwan
Results and Publications
Publication and dissemination plan
The 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 statement
The 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.
Intention to publish date
30/06/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30719293 (added 02/04/2020)