NCT07690280

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026May 2027

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 8, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

July 1, 2026

Last Update Submit

July 8, 2026

Conditions

Keywords

DementiaFamily caregiverBehavioral and Psychological Symptoms of DementiaPsychoeducationSymptom monitoring

Outcome Measures

Primary Outcomes (1)

  • Caregiver Self-Efficacy in Managing Behavioral and Psychological Symptoms of Dementia

    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 Outcomes (2)

  • Behavioral and Psychological Symptoms of Dementia

    Baseline and Week 6

  • Caregiver Burden

    Baseline and Week 6

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Web-Based Psychoeducation and Symptom-Monitoring Program

Control Group

NO INTERVENTION

Participants receive usual care without access to the web-based psychoeducation and symptom-monitoring program during the study period.

Interventions

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.

Intervention Group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lotung Poh-Ai Hospital

Luodong, Yilan County, 265, Taiwan

RECRUITING

Related Publications (3)

  • 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: 11773226BACKGROUND
  • 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: 25731881BACKGROUND
  • 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: 36951611BACKGROUND

MeSH Terms

Conditions

DementiaBehavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Shan-Hua Chen

    Lotung Poh-Ai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be assigned sequentially in alternating order to either the intervention group or the control group. Both groups will be followed concurrently throughout the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

July 8, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared because informed consent does not include permission for data sharing outside this study.

Locations