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Recruiting NCT07690280

Web-Based Psychoeducation for Dementia Caregivers

No phase Interventional Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Web-Based Psychoeducation and Symptom-Monitoring Program.
Who it may be relevant to
Registry conditions: Dementia. Basic parameters: 20 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Web-Based Psychoeducation and Symptom-Monitoring Program to Enhance Dementia Caregiver Self-Efficacy in Managing BPSD

Overview

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.

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).

Interventions

  • Behavioral Web-Based Psychoeducation and Symptom-Monitoring Program
    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.

Primary outcome measures

  • Caregiver Self-Efficacy in Managing Behavioral and Psychological Symptoms of Dementia [Time frame: Baseline and Week 6]
Secondary outcome measures (2)
  • Behavioral and Psychological Symptoms of Dementia [Time frame: Baseline and Week 6]
  • Caregiver Burden [Time frame: Baseline and Week 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • Lotung Poh-Ai Hospital — Luodong

Publications

  • 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. PMID 11773226
  • 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. PMID 25731881
  • 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. PMID 36951611

Identifiers

NCT: NCT07690280 · LOPAH-BPSD-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗