Interventions and Implements for coping with the behavioral and psychological symptoms of dementia: perspectives from family caregivers
| ISRCTN | ISRCTN50312942 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50312942 |
| Secondary identifying numbers | EC1110102 |
- Submission date
- 29/04/2022
- Registration date
- 10/05/2022
- Last edited
- 10/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
In Taiwan, it is estimated that one in every 12 persons aged 65 years and more and one in every 5 persons aged 80 years or more are diagnosed with dementia. Dementia is characterized by dysfunction or loss of memory, orientation, attention, language, judgement, and reasoning, and people living with dementia (PWD) become more dependent on their carers when the disease progresses. In Taiwan and globally, challenges are being faced because of the rapidly increased numbers of dementia recipients and family caregivers (FCGs) of PWD. It is estimated that in Taiwan, 6% of PWD are institutionalized, whereas 93% of PWD live at home and 55% are cared for by their family members, a percentage similar to that in Western countries. Behavioral and psychological symptoms of dementia (BPSD) such as agitation, aggression, calling out repeatedly, sleep disturbance, wandering and apathy affect up to 90% of PWD and are associated with poor outcomes such as distress in both the person with dementia and the carer. Caring for a FWD can be described as “challenging’ when it causes distress to the person or the carers or family carers in particular. The aims of thisd study are to explore which behavioural and psychological symptoms of dementia (BPSD) affect the well-being of family care givers (FCGs) the most and how and in what ways could FCGs cope each of the problem behaviors. By the end, tailored interventions are developed to support FCGs in home settings to enhance the positive outcomes from caring for a person with dementia.
Who can participate?
Family caregivers of people living with dementia and their care recipients.
What does the study involve?
This study includes three phases. In phase I the effective BPSD guideline and strategies will be explored, collected, and edited into a handbook. The draft of the handbook would be approved by experts and used as the guideline for BPSD educational training programs. In phase II family caregivers (FCGs) and people living with dementia (PWD) are recruited from Chia-Yi and Tai-Chung in Taiwan respectively. Family caregivers who have experienced a negative caring experience possibly resulting from BPSD of the dementia care recipient, are recruited to participate in a 24-hour BPSD educational training program. The 24-hour BPSD educational training programs will be conducted for 3 months. Family caregivers are also interviewed before the start of training programs, followed by two interviews every 2 months before finishing their BPSD educational training. This would help the researcher to explore the initial caring attitudes and experiences of FCGs in home settings and to investigate whether those attitudes and caring experiences are changed into positive ones. In phase III the researcher and experts from the field will visit the FCGs and PWD at home. During the home visits, the home environment and interaction between caregiver and care recipient will be observed, asked and noted down to examine how and in what ways family caregivers deliver care to recipients in family settings.
What are the possible benefits and risks of participating?
The family caregivers in particular may not only benefit from gaining knowledge of dementia but also exchange ideas and experiences with others who join the BPSD educational training programs in terms of coping and management in home settings. During the home visits there is a risk that care recipients refuse or feel uncomfortable allowing 'strangers' (e.g., researchers and experts) to enter their house.
Where is the study run from?
National Health Research Institutes (Taiwan)
When is the study starting and how long is it expected to run for?
December 2021 to December 2024
Who is funding the study?
National Health Research Institutes (Taiwan)
Who is the main contact?
Dr Chia-Ming Yen
cmyen@nhri.edu.tw
Contact information
Principal Investigator
No.8, Syuefu West Road
Hu-wei Township, Yun-lin County
632
Taiwan
 ORCID ID |
0000-0002-9774-8634 |
|---|---|
| Phone | +886 (0)5 6325080 |
| cmyen@nhri.edu.tw |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available |
| Scientific title | From knowledge to practice: interventions and implementation for coping with behaviour problems in dementia care |
| Study acronym | BPSD intervention: Family caregivers |
| Study objectives | This study explores which behavioral and psychological symptoms of dementia (BPSD) affect the well-being of family caregivers (FCGs) the most and how and in what ways to help FCGs manage these problem behaviors. This study develops tailored interventions to support FCGs in accordance with the reported BPSD from FCGs in home settings. |
| Ethics approval(s) | Approved 17/03/2022, Ethics Committee of National Health Research Institutes (No.35, Keyan Road, Zhunan, Miaoli County. Taiwan, Republic of China; +886 (0)37 206166 ext 38602, +886 (0)37 58310; nirb@nhri.edu.tw), ref: EC1110102 |
| Health condition(s) or problem(s) studied | BPSD interventions for family caregivers of people living with dementia |
| Intervention | This study includes three phases, each phase has its own design and criteria. In phase I the effective BPSD guideline and strategies will be explored, collected, and edited into a handbook. The draft of the handbook would be approved by experts and used as the guideline for BPSD educational training programs. In phase II 12 dyads of family caregivers (FCGs) and people living with dementia (PWD) are recruited from Chia-Yi and Tai-Chung in Taiwan respectively. Family caregivers who are experienced a negative caring experience possibly resulting from BPSD of the dementia care recipient, are recruited to participate in a 24-hour BPSD educational training program. The 24-hour BPSD educational training programs will be conducted for 3 months. Family caregivers are also interviewed before the start of training programs, followed by two interviews every 2 months before finishing their BPSD educational training. This would help the researcher to explore 1) the initial caring attitudes and experiences of FCGs in home settings and 2) to investigate whether those attitudes and caring experiences are changed into positive ones. In phase III the researcher and experts from the field will visit the dyads of FCGs and PWD at home. During the home visits, the home environment and interaction between caregiver and care recipient will be observed, asked and noted down to examine how and in what ways family caregivers deliver care to recipients in family settings. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Coping and skill management in the home setting evaluated by the researcher via interviews (self-report from the family caregivers) at baseline, 0, 3, 6 and 9 months 2. The interaction between caregivers and care recipients evaluated by the researcher and frontline workers (e.g. a neurologist or social worker) at three home visits in May, August and October 2022 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/12/2021 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Family caregivers of people living with dementia and the care recipients |
| Key exclusion criteria | Early-onset dementia |
| Date of first enrolment | 01/04/2022 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Yun-Lin County
632
Taiwan
Sponsor information
Research organisation
No.35 Keyan Road
Zhu-nan, Miao-li
350
Taiwan
| Phone | +886 (0)37 246166 |
|---|---|
| hsinlingyeh@nhri.edu.tw | |
| Website | https://www.nhri.edu.tw/eng/ |
"ROR" |
https://ror.org/02r6fpx29 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- NHRI
- Location
- Taiwan
Private sector organisation / Universities (academic only)
- Alternative name(s)
- CMU
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | One review article will look at the studies between 2000 and 2022, clinical trials and qualitative studies in particular on coping and management of BPSD among family caregivers of people living with dementia. The second manuscript is the protocol of the study. High-impact peer-reviewed journals are preferred. |
| IPD sharing plan | Not expected to be made available due to cultural norms. |
Editorial Notes
09/05/2022: Trial's existence confirmed by the Ethics Committee of National Health Research Institutes.
