- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07690280
Web-Based Psychoeducation for Dementia Caregivers
A Web-Based Psychoeducation and Symptom-Monitoring Program to Enhance Dementia Caregiver Self-Efficacy in Managing BPSD
Behavioral and psychological symptoms of dementia (BPSD), such as agitation, anxiety, depression, sleep disturbance, and apathy, are common among people with dementia and often increase the burden on family caregivers. Many caregivers have limited knowledge and confidence in managing these symptoms.
This study aims to evaluate the effectiveness of a 6-week web-based psychoeducation and BPSD symptom-monitoring program in improving caregivers' self-efficacy in managing BPSD. Community-dwelling family caregivers of people with dementia will be recruited from the neurology outpatient clinic of Lotung Poh-Ai Hospital in Taiwan.
Participants will be assigned sequentially to either an intervention group receiving web-based psychoeducation, BPSD symptom monitoring, and usual care, or a control group receiving usual care alone. The primary outcome is caregiver self-efficacy. Secondary outcomes include BPSD severity and caregiver burden.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Behavioral and psychological symptoms of dementia (BPSD) affect most people living with dementia during the course of the disease and are associated with increased caregiver burden, psychological distress, and reduced quality of life. Family caregivers frequently experience difficulties in recognizing BPSD, identifying possible triggers, and applying appropriate management strategies. Although web-based psychoeducation has shown potential benefits for dementia caregivers, evidence regarding its effectiveness in improving caregiver self-efficacy through the integration of structured symptom monitoring remains limited.
This study will evaluate a six-week web-based psychoeducation and BPSD symptom-monitoring program developed for family caregivers of community-dwelling people with dementia. The intervention is delivered through an AppSheet-based online platform and includes six educational modules, BPSD symptom diary recording based on the Neuropsychiatric Inventory Questionnaire (NPI-Q), weekly reminders, and online support when needed. Educational topics include understanding dementia and BPSD, symptom recognition, communication strategies, daily care, caregiver self-care, and community support resources.
This study uses a quasi-experimental two-group pretest-posttest parallel design. Approximately 80 family caregivers will be recruited from the neurology outpatient clinic of Lotung Poh-Ai Hospital, Taiwan. Participants will be assigned sequentially in alternating order to either the intervention group or the usual care control group.
Outcome assessments will be conducted at baseline (Week 0) and immediately after the six-week intervention (Week 6) for both groups. Participants in the intervention group will additionally complete a follow-up assessment at Week 10 to evaluate maintenance of intervention effects.
The primary outcome is caregiver self-efficacy measured using the Revised Scale for Caregiving Self-Efficacy (RSCSE). Secondary outcomes include BPSD severity measured using the Neuropsychiatric Inventory Questionnaire (NPI-Q) and caregiver burden measured using the Zarit Burden Interview (ZBI-22).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shan-Hua Chen
- Phone Number: 5430 +88639543131
- Email: c887034@mail.pohai.org.tw
Study Locations
-
-
Yilan County
-
Luodong, Yilan County, Taiwan, 265
- Recruiting
- Lotung Poh-Ai Hospital
-
Contact:
- Shan-Hua Chen
- Phone Number: 5430 +88639543131
- Email: c887034@mail.pohai.org.tw
-
Principal Investigator:
- Shan-Hua Chen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Family caregivers aged 20 to 90 years.
- The primary caregiver of a community-dwelling person diagnosed with dementia.
- Able to read and understand Chinese.
- Able to use a smartphone, tablet, or computer with Internet access.
- Willing to provide written informed consent and comply with study procedures.
Exclusion Criteria:
- Caregivers of persons with dementia who reside in a long-term care institution.
- Unable to complete study procedures because of cognitive, physical, or communication impairment.
- Currently participating in another intervention study that may influence the study outcomes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants receive a 6-week web-based psychoeducation and symptom-monitoring program in addition to usual care.
The intervention includes six web-based educational modules, BPSD symptom monitoring, weekly reminders, and online consultation when needed.
|
Participants assigned to the intervention group receive a 6-week web-based psychoeducation and symptom-monitoring program in addition to usual care.
The program includes six web-based educational modules on dementia care, BPSD symptom monitoring, weekly reminders to support engagement, and online consultation with the research team when needed.
The intervention is designed to improve caregiver self-efficacy in managing behavioral and psychological symptoms of dementia.
|
|
No Intervention: Control Group
Participants receive usual care without access to the web-based psychoeducation and symptom-monitoring program during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Self-Efficacy in Managing Behavioral and Psychological Symptoms of Dementia
Time Frame: Baseline and Week 6
|
Caregiver self-efficacy will be assessed using the Revised Scale for Caregiving Self-Efficacy (RSCSE).
The primary outcome is the change in caregiver self-efficacy from baseline to Week 6 between the intervention and control groups.
|
Baseline and Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral and Psychological Symptoms of Dementia
Time Frame: Baseline and Week 6
|
Behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q).
The secondary outcome is the change in symptom severity and caregiver distress from baseline to Week 6 between the intervention and control groups.
|
Baseline and Week 6
|
|
Caregiver Burden
Time Frame: Baseline and Week 6
|
Caregiver burden will be assessed using the 22-item Zarit Burden Interview (ZBI-22).
The secondary outcome is the change in caregiver burden from baseline to Week 6 between the intervention and control groups.
|
Baseline and Week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shan-Hua Chen, Lotung Poh-Ai Hospital
Publications and helpful links
General Publications
- Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015 Mar 2;350:h369. doi: 10.1136/bmj.h369.
- Steffen AM, McKibbin C, Zeiss AM, Gallagher-Thompson D, Bandura A. The revised scale for caregiving self-efficacy: reliability and validity studies. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P74-86. doi: 10.1093/geronb/57.1.p74.
- Yu Y, Xiao L, Ullah S, Meyer C, Wang J, Pot AM, He JJ. The effectiveness of internet-based psychoeducation programs for caregivers of people living with dementia: a systematic review and meta-analysis. Aging Ment Health. 2023 Sep-Oct;27(10):1895-1911. doi: 10.1080/13607863.2023.2190082. Epub 2023 Mar 23.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOPAH-BPSD-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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