DementiaNCT07690280
Web-Based Psychoeducation for Dementia Caregivers
A study testing Web-Based Psychoeducation and Symptom-Monitoring Program in people with Dementia, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Dementia
- What is being tested?
- Web-Based Psychoeducation and Symptom-Monitoring Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jul 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Family caregivers aged 20 to 90 years.
- Currently the primary caregiver of a community-dwelling person diagnosed with dementia by a physician.
- Able to read and understand Chinese and able to use a smartphone, tablet, or computer with Internet access.
- Willing to participate in the study and complete the required study procedures and questionnaires.
Who cannot join
- Unable to read or understand Chinese.
- Currently caring for a person with dementia who resides in a long-term care institution, such as a nursing home or residential care facility.
- Unable to comply with study procedures or complete the questionnaires due to physical or psychological conditions, as assessed by the researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Lotung Poh-Ai Hospital
Luodong, Yilan County, 265
Shan-Hua Chen, +88639543131 ext. 5430, c887034@mail.pohai.org.tw
Shan-Hua Chen
About this study
Official title: 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 through healthcare, care, or community service settings and related activities 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.
Read the detailed description
Behavioral and psychological symptoms of dementia (BPSD) affect many 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 web-based educational modules and BPSD symptom diary recording. The symptom diary allows caregivers to record symptom types, circumstances, possible triggers, management strategies, and outcomes. Educational topics include understanding dementia, recognition of BPSD and possible triggers, BPSD management and caregiving strategies, communication and home 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 through healthcare, care, or community service settings and related activities in 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 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 measured using the Neuropsychiatric Inventory Questionnaire (NPI-Q) and caregiver burden measured using the Zarit Burden Interview (ZBI).
- Conditions
- Dementia
- Being tested
- Web-Based Psychoeducation and Symptom-Monitoring Program
- Keywords
- Dementia, Family caregiver, Behavioral and Psychological Symptoms of Dementia, Psychoeducation, Symptom monitoring
- Medical subject headings
- Dementia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Psychoeducation and Symptom-Monitoring ProgramBehavioural
Participants assigned to the intervention group receive a 6-week web-based psychoeducation and BPSD symptom-monitoring program in addition to usual care. The program provides web-based educational content on dementia care, recognition of BPSD and possible triggers, BPSD management and caregiving strategies, communication and home care, caregiver self-care, and community support resources. Participants may also use the online platform to record BPSD symptoms, circumstances, possible triggers, management strategies, and outcomes. The intervention is designed to improve caregiver self-efficacy in managing behavioral and psychological symptoms of dementia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive a 6-week web-based psychoeducation and BPSD symptom-monitoring program in addition to usual care. The intervention includes web-based educational content on dementia care and BPSD management, as well as BPSD symptom diary recording. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 6
Secondary outcomes (2)
Behavioral and Psychological Symptoms of Dementia
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.
Measured: Baseline and Week 6
Caregiver Burden
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.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start8 Jul 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lotung Poh-Ai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shan-Hua Chen, Lotung Poh-Ai Hospital
- Investigators
- Shan-Hua Chen, Principal investigator, Lotung Poh-Ai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690280
- Sponsor's protocol ID
- LOPAH-BPSD-2026-01
- Status last verified
- Sep 2026
- First submitted
- 1 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared because informed consent does not include permission for data sharing outside this study.
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.
PubMed 11773226Kales 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.
PubMed 25731881Yu 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.
PubMed 36951611
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-Based Psychoeducation and Symptom-Monitoring Program to Enhance Dementia Caregiver Self-Efficacy in Managing BPSD
- ClinicalTrials.gov ID
- NCT07690280
- Acronym / sponsor ID
- LOPAH-BPSD-2026-01
- Conditions
- Dementia
- Keywords
- Dementia, Family caregiver, Behavioral and Psychological Symptoms of Dementia, Psychoeducation, Symptom monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lotung Poh-Ai HospitalUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 through healthcare, care, or community service settings and related activities 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 many 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 web-based educational modules and BPSD symptom diary recording. The symptom diary allows caregivers to record symptom types, circumstances, possible triggers, management strategies, and outcomes. Educational topics include understanding dementia, recognition of BPSD and possible triggers, BPSD management and caregiving strategies, communication and home 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 through healthcare, care, or community service settings and related activities in 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 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 measured using the Neuropsychiatric Inventory Questionnaire (NPI-Q) and caregiver burden measured using the Zarit Burden Interview (ZBI).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Web-Based Psychoeducation and Symptom-Monitoring ProgramParticipants receive a 6-week web-based psychoeducation and BPSD symptom-monitoring program in addition to usual care. The intervention includes web-based educational content on dementia care and BPSD management, as well as BPSD symptom diary recording. |
| Control Group | No intervention | –Participants receive usual care without access to the web-based psychoeducation and symptom-monitoring program during the study period. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Family caregivers aged 20 to 90 years.
- Currently the primary caregiver of a community-dwelling person diagnosed with dementia by a physician.
- Able to read and understand Chinese and able to use a smartphone, tablet, or computer with Internet access.
- Willing to participate in the study and complete the required study procedures and questionnaires.
Key exclusion criteria (3 listed)
- Unable to read or understand Chinese.
- Currently caring for a person with dementia who resides in a long-term care institution, such as a nursing home or residential care facility.
- Unable to comply with study procedures or complete the questionnaires due to physical or psychological conditions, as assessed by the researcher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Psychoeducation and Symptom-Monitoring ProgramParticipants assigned to the intervention group receive a 6-week web-based psychoeducation and BPSD symptom-monitoring program in addition to usual care. The program provides web-based educational content on dementia care, recognition of BPSD and possible triggers, BPSD management and caregiving strategies, communication and home care, caregiver self-care, and community support resources. Participants may also use the online platform to record BPSD symptoms, circumstances, possible triggers, management strategies, and outcomes. The intervention is designed to improve caregiver self-efficacy in managing behavioral and psychological symptoms of dementia. | Behavioural | Intervention Group |
Primary outcome
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.
2 secondary outcomes
Behavioral and Psychological Symptoms of Dementia
Time frame: Baseline and Week 6
Caregiver Burden
Time frame: Baseline and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 11773226Steffen 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.
- Background: PubMed 25731881Kales 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.
- Background: PubMed 36951611Yu 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.
- Individual participant dataSharing planned: No. No individual participant data will be shared because informed consent does not include permission for data sharing outside this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shan-Hua Chen principal investigator
Lotung Poh-Ai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Psychoeducation and Symptom-Monitoring Program in people with Dementia, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shan-Hua Chen (+88639543131 ext. 5430, c887034@mail.pohai.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Self-Efficacy in Managing Behavioral and Psychological Symptoms of Dementia (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07690280, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.