DementiaNCT07081750
Dyadic Personalized Home-Based Activity Program for Mild-to-Moderate Dementia Patients Post-Discharge
A study testing Dyadic personalized home-based activity program intervention and Routine care in people with Dementia, run by Fujian Medical University at 1 site in China.
Trial summary
This interventional study aims to evaluate the efficacy of a dyadic personalized home-based activity program in managing behavioral and psychological symptoms of dementia (BPSD) among home-dwelling people living with mild-to-moderate dementia post-discharge. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Dyadic personalized home-based activity program intervention and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2025to 30 Jun 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged ≥ 60 years;
- Have a diagnosis of dementia according to ICD-10 criteria, with a Clinical Dementia Rating (CDR) score of 1-2 (mild-to-moderate stage);
- Retain basic verbal communication ability;
- Present at least one neuropsychiatric symptom (a score ≥ 1 on any single item) within the past month, as evaluated by the Neuropsychiatric Inventory (NPI);
- Be medically fit for hospital discharge and scheduled to receive home care post-discharge;
- Be willing to participate in this study and provide written informed consent.
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- Family Caregivers
- Be aged ≥ 18 years;
- Have kinship with the patient (e.g., spouse, children, siblings, etc.);
- Undertake primary care responsibilities on an unpaid, non-professional basis, and have the longest average daily care hours among all family caregivers;
- Be willing to assume continuous home care responsibilities for at least 3 months post-discharge;
- Have intact verbal communication skills;
- Possess basic proficiency in operating the WeChat application (a widely used social communication application in China), including independently sending and receiving messages, as well as making voice and video calls；
- Be willing to participate in this study and provide written informed consent.
Who cannot join
- Have severe somatic diseases (e.g., malignant tumors, heart failure, physical disabilities) or severe psychiatric disorders;
- Have severe visual or hearing impairment;
- Have dementia secondary to the following conditions: central nervous system diseases (e.g., encephalitis, brain tumors, epilepsy, multiple sclerosis, Parkinson's disease), nutritional and metabolic disorders (e.g., thyroid dysfunction, vitamin B12 or folate deficiency), substance or alcohol dependence, and other potential causes of secondary dementia;
- Suffer from severe physical or mental disorders, extreme debilitation, long-term bedridden status, end-stage disease with a life expectancy of less than six months, or be unable to cooperate with or tolerate the study intervention;
- Be enrolled in any other clinical research that may interfere with the outcomes of this study.
- Family Caregivers
Show all 9Show fewer
- Have severe somatic diseases (e.g., malignant tumors, heart failure, physical disabilities) or severe psychiatric disorders;
- Have severe visual or hearing impairment;
- Be enrolled in any other clinical research that may interfere with the outcomes of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital Affiliated to Fujian Medical University
Fujian, Fuzhou
Xiaozhen Fu, 15160301901, 15160301901@163.com
About this study
Official title: Construction and Efficacy Evaluation of a Dyadic Personalized Home-Based Activity Intervention Program for Patients Discharged With Mild to Moderate Dementia and Behavioral and Psychological Symptoms
This interventional study aims to evaluate the efficacy of a dyadic personalized home-based activity program in managing behavioral and psychological symptoms of dementia (BPSD) among home-dwelling people living with mild-to-moderate dementia post-discharge. The main question it aims to answer is:
Does the dyadic personalized home-based activity program significantly reduce BPSD in individuals post-discharge with mild-to-moderate dementia?
Read more
Researchers will compare individuals living with mild to moderate dementia who are receiving routine care to see if the dyadic personalized home-based activity program is effective for BPSD.
Participants will:
- In-hospital stage: A personalized home-based activity intervention plan is tailored for patients. Family caregivers receive professional training on care skills related to home-based activities and are provided with corresponding activity resources and support.
- Post-discharge home-based stage: The intervention is delivered by family caregivers for a total of 12 weeks. The intervention is recommended to be performed twice per week, with each session lasting about 30 minutes in accordance with the patient's individual tolerance. Intermittent rest is advised (e.g., a 2-3 minute break every 10 minutes). The weekly intervention frequency and session duration can be flexibly adjusted according to the family caregivers' schedule and the patient's condition, including mood fluctuations and physical discomfort. Family caregivers are required to record the patient's activity participation, subjective feelings and behavioral responses, and submit regular feedback to the research team. Based on feedback from patients and family caregivers, the research team will conduct dynamic adjustments and continuous optimization of the intervention program throughout the study.
- Conditions
- Dementia
- Being tested
- Dyadic personalized home-based activity program intervention, Routine care
- Keywords
- dementia, behavioral and psychological symptoms, home-based, activity
- Medical subject headings
- Dementia, Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic personalized home-based activity program interventionBehavioural
- In - hospital stage: A personalized home - based activity intervention program is tailored for patients. Family caregivers receive training on care skills related to home - based activities and are provided with corresponding activity resources and support.
- Post-discharge home-based stage: The intervention is delivered by family caregivers for a total of 12 weeks.
Routine careOther
Participants will receive routine care consisting of standard hospitalization treatment, basic caregiver education on behavioral and psychological symptoms of dementia (BPSD), routine discharge instructions (including general home activity recommendations without personalized intervention assessment, planning or implementation), and routine post-discharge follow-up for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dyadic personalized home-based activity program intervention | Experimental | 1. In - hospital stage: A personalized home - based activity intervention program is tailored for patients. Family caregivers receive training on care skills related to home - based activities and are provided with corresponding activity resources and support.
2. Post-discharge home-based stage: The intervention is delivered by family caregivers for a total of 12 weeks. Receives: Behavioral: Dyadic personalized home-based activity program intervention |
| Routine care | Other | Participants will receive routine care consisting of standard hospitalization treatment, basic caregiver education on behavioral and psychological symptoms of dementia (BPSD), routine discharge instructions (including general home activity recommendations without personalized intervention assessment, planning or implementation), and routine post-discharge follow-up for 12 weeks. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral and Psychological Symptoms of Dementia
Assessment using the Neuropsychiatric Inventory (NPI) yields scores ranging from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms
Measured: Baseline and post-intervention (at the end of week 12)
Caregiver Distress of Behavioral and Psychological Symptoms of Dementia
Assessment using the caregiver distress section of the Neuropsychiatric Inventory (NPI) yields scores ranging from 0 to 60, with higher scores indicating greater caregiver distress levels
Measured: Baseline and post-intervention (at the end of week 12)
Secondary outcomes (16)
Cognitive Function of Dementia Patients
Assessment using the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog) yields scores ranging from 0 to 70, with higher scores indicating more severe cognitive impairment
Measured: Baseline and post-intervention (at the end of week 12)
Activities of Daily Living of Dementia Patients
Assessment using the Activity of Daily Living (ADL) scale yields scores ranging from 20 to 80, with higher scores indicating more severe impairment in daily living activities.
Measured: Baseline and post-intervention (at the end of week 12)
Apathy of Dementia Patients
Assessment using the Apathy Evaluation Scale-Informant version (AES-I) yields scores ranging from 18 to 72, with higher scores indicating more severe apathy symptoms
Measured: Baseline and post-intervention (at the end of week 12)
Agitation of Dementia Patients
Assessment using the Cohen-Mansfield Agitation Inventory (CMAI) yields scores ranging from 29 to 203, with higher scores indicating more severe agitated behaviors
Measured: Baseline and post-intervention (at the end of week 12)
Quality of Life in Dementia
Assessment using the Quality of Life-Alzheimer's Disease (QOL-AD) scale yields total scores ranging from 13 to 52, with higher scores indicating better quality of life
Measured: Baseline and post-intervention (at the end of week 12)
Caregiver Readiness for Hospital Discharge
Assessment using the Caregiver Preparedness Scale (CPS) yields total scores ranging from 0 to 32, with higher scores indicating better discharge readiness.
Measured: Baseline（on the day of patient discharge）
Caregiver Burden
Assessment using the Caregiver Burden Inventory (CBI) yields scores ranging from 0 to 88, with a total score of <21 indicates no or mild burden, 21-39 suggests moderate burden, and ≥40 reflects severe burden.
Measured: Baseline and post-intervention (at the end of week 12)
Self Efficacy of Caregivers
Assessment using the General Self-Efficacy Scale (GSES) yields scores ranging from 10 to 40, with higher scores indicating greater self-efficacy
Measured: Baseline and post-intervention (at the end of week 12)
Perceived Social Support of Caregivers
Assessment using the Perceived Social Support Scale (PSSS) yields scores ranging from 12 to 84, with higher scores indicating greater perceived social support
Measured: Baseline and post-intervention (at the end of week 12)
Depression of Dementia Patients
Assessment using the 24-item Hamilton Depression Scale (HAMD-24) yields total scores ranging from 0 to 78, with higher scores indicating more severe depressive symptoms. Specifically, scores <8 suggest no depression, 8-20 indicate possible depression, 21-35 confirm clinically significant depression, and >35 reflect severe depression
Measured: Baseline and post-intervention (at the end of week 12)
Depression of Caregivers
Assessment using the 24-item Hamilton Depression Scale (HAMD-24) yields total scores ranging from 0 to 78, with higher scores indicating more severe depressive symptoms. Specifically, scores <8 suggest no depression, 8-20 indicate possible depression, 21-35 confirm clinically significant depression, and >35 reflect severe depression
Measured: Baseline and post-intervention (at the end of week 12)
Anxiety of Dementia Patients
Assessment using the Hamilton Anxiety Scale (HAMA) yields total scores ranging from 0 to 56, with ≥29 indicating probable severe anxiety, ≥21 reflecting definite significant anxiety, ≥14 confirming anxiety presence, >7 suggesting possible anxiety, and <7 demonstrating no anxiety symptoms.
Measured: Baseline and post-intervention (at the end of week 12)
Anxiety of Caregivers
Assessment using the Hamilton Anxiety Scale (HAMA) yields total scores ranging from 0 to 56, with ≥29 indicating probable severe anxiety, ≥21 reflecting definite significant anxiety, ≥14 confirming anxiety presence, >7 suggesting possible anxiety, and <7 demonstrating no anxiety symptoms.
Measured: Baseline and post-intervention (at the end of week 12)
Family Quality of Life in Dementia
Assessment using the Family Quality of Life in Dementia Scale (FQOL-D) yields total scores ranging from 13 to 52, with higher scores indicating better family quality of life
Measured: Baseline and post-intervention (at the end of week 12)
Family Adaptability and Cohesion in Dementia
Assessment was conducted using the Chinese Version of the Family Adaptability and Cohesion Scale, Second Edition (FACES II-CV), which comprises two subscales: Cohesion and Adaptability (15 items each, with subscale scores ranging from 15 to 75; higher scores indicate stronger family cohesion or adaptability
Measured: Baseline and post-intervention (at the end of week 12)
Number of Participants with Intervention-Related Adverse Events
Measured: Post-intervention (at the end of week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start20 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaozhen Fu, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081750
- Sponsor's protocol ID
- FY-EC-2025-304
- Status last verified
- May 2026
- First submitted
- 6 Jul 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Efficacy Evaluation of a Dyadic Personalized Home-Based Activity Intervention Program for Patients Discharged With Mild to Moderate Dementia and Behavioral and Psychological Symptoms
- ClinicalTrials.gov ID
- NCT07081750
- Acronym / sponsor ID
- FY-EC-2025-304
- Conditions
- Dementia
- Keywords
- dementia, behavioral and psychological symptoms, home-based, activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Jul 2025 (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.
This interventional study aims to evaluate the efficacy of a dyadic personalized home-based activity program in managing behavioral and psychological symptoms of dementia (BPSD) among home-dwelling people living with mild-to-moderate dementia post-discharge. The main question it aims to answer is:
Does the dyadic personalized home-based activity program significantly reduce BPSD in individuals post-discharge with mild-to-moderate dementia?
Researchers will compare individuals living with mild to moderate dementia who are receiving routine care to see if the dyadic personalized home-based activity program is effective for BPSD.
Participants will:
- In-hospital stage: A personalized home-based activity intervention plan is tailored for patients. Family caregivers receive professional training on care skills related to home-based activities and are provided with corresponding activity resources and support.
- Post-discharge home-based stage: The intervention is delivered by family caregivers for a total of 12 weeks. The intervention is recommended to be performed twice per week, with each session lasting about 30 minutes in accordance with the patient's individual tolerance. Intermittent rest is advised (e.g., a 2-3 minute break every 10 minutes). The weekly intervention frequency and session duration can be flexibly adjusted according to the family caregivers' schedule and the patient's condition, including mood fluctuations and physical discomfort. Family caregivers are required to record the patient's activity participation, subjective feelings and behavioral responses, and submit regular feedback to the research team. Based on feedback from patients and family caregivers, the research team will conduct dynamic adjustments and continuous optimization of the intervention program throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyadic personalized home-based activity program intervention | Experimental | Behavioral: Dyadic personalized home-based activity program intervention1. In - hospital stage: A personalized home - based activity intervention program is tailored for patients. Family caregivers receive training on care skills related to home - based activities and are provided with corresponding activity resources and support. 2. Post-discharge home-based stage: The intervention is delivered by family caregivers for a total of 12 weeks. |
| Routine care | Other | Other: Routine careParticipants will receive routine care consisting of standard hospitalization treatment, basic caregiver education on behavioral and psychological symptoms of dementia (BPSD), routine discharge instructions (including general home activity recommendations without personalized intervention assessment, planning or implementation), and routine post-discharge follow-up for 12 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be aged ≥ 60 years;
- Have a diagnosis of dementia according to ICD-10 criteria, with a Clinical Dementia Rating (CDR) score of 1-2 (mild-to-moderate stage);
- Retain basic verbal communication ability;
- Present at least one neuropsychiatric symptom (a score ≥ 1 on any single item) within the past month, as evaluated by the Neuropsychiatric Inventory (NPI);
- Be medically fit for hospital discharge and scheduled to receive home care post-discharge;
Key exclusion criteria (9 listed)
- Have severe somatic diseases (e.g., malignant tumors, heart failure, physical disabilities) or severe psychiatric disorders;
- Have severe visual or hearing impairment;
- Have dementia secondary to the following conditions: central nervous system diseases (e.g., encephalitis, brain tumors, epilepsy, multiple sclerosis, Parkinson's disease), nutritional and metabolic disorders (e.g., thyroid dysfunction, vitamin B12 or folate deficiency), substance or alcohol dependence, and other potential causes of secondary dementia;
- Suffer from severe physical or mental disorders, extreme debilitation, long-term bedridden status, end-stage disease with a life expectancy of less than six months, or be unable to cooperate with or tolerate the study intervention;
- Be enrolled in any other clinical research that may interfere with the outcomes of this study.
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 |
|---|---|---|
| Dyadic personalized home-based activity program intervention1. In - hospital stage: A personalized home - based activity intervention program is tailored for patients. Family caregivers receive training on care skills related to home - based activities and are provided with corresponding activity resources and support. 2. Post-discharge home-based stage: The intervention is delivered by family caregivers for a total of 12 weeks. | Behavioural | Dyadic personalized home-based activity program intervention |
| Routine careParticipants will receive routine care consisting of standard hospitalization treatment, basic caregiver education on behavioral and psychological symptoms of dementia (BPSD), routine discharge instructions (including general home activity recommendations without personalized intervention assessment, planning or implementation), and routine post-discharge follow-up for 12 weeks. | Other | Routine care |
Primary outcome
Behavioral and Psychological Symptoms of Dementia
Time frame: Baseline and post-intervention (at the end of week 12)
Assessment using the Neuropsychiatric Inventory (NPI) yields scores ranging from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms
Caregiver Distress of Behavioral and Psychological Symptoms of Dementia
Time frame: Baseline and post-intervention (at the end of week 12)
Assessment using the caregiver distress section of the Neuropsychiatric Inventory (NPI) yields scores ranging from 0 to 60, with higher scores indicating greater caregiver distress levels
16 secondary outcomes
Cognitive Function of Dementia Patients
Time frame: Baseline and post-intervention (at the end of week 12)
Activities of Daily Living of Dementia Patients
Time frame: Baseline and post-intervention (at the end of week 12)
Apathy of Dementia Patients
Time frame: Baseline and post-intervention (at the end of week 12)
Agitation of Dementia Patients
Time frame: Baseline and post-intervention (at the end of week 12)
Quality of Life in Dementia
Time frame: Baseline and post-intervention (at the end of week 12)
Caregiver Readiness for Hospital Discharge
Time frame: Baseline（on the day of patient discharge）
Caregiver Burden
Time frame: Baseline and post-intervention (at the end of week 12)
Self Efficacy of Caregivers
Time frame: Baseline and post-intervention (at the end of week 12)
Perceived Social Support of Caregivers
Time frame: Baseline and post-intervention (at the end of week 12)
Depression of Dementia Patients
Time frame: Baseline and post-intervention (at the end of week 12)
Depression of Caregivers
Time frame: Baseline and post-intervention (at the end of week 12)
Anxiety of Dementia Patients
Time frame: Baseline and post-intervention (at the end of week 12)
Anxiety of Caregivers
Time frame: Baseline and post-intervention (at the end of week 12)
Family Quality of Life in Dementia
Time frame: Baseline and post-intervention (at the end of week 12)
Family Adaptability and Cohesion in Dementia
Time frame: Baseline and post-intervention (at the end of week 12)
Number of Participants with Intervention-Related Adverse Events
Time frame: Post-intervention (at the end of week 12)
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 11 May 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic personalized home-based activity program intervention and Routine care in people with Dementia, run by Fujian Medical University at 1 site in China.
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 14 inclusion and 9 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 11 May 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 China. 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 Xiaozhen Fu (15160301901, 15160301901@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral and Psychological Symptoms of Dementia (time frame: Baseline and post-intervention (at the end of week 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.