Condition category
Mental and Behavioural Disorders
Date applied
15/12/2017
Date assigned
18/01/2018
Last edited
18/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

31/05/2018

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

31/03/2018

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

Publication citations

Additional files

Editorial Notes

18/01/2018: Internal review.