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NCT Number: NCT07081750

Dyadic Personalized Home-Based Activity Program for Mild-to-Moderate Dementia Patients Post-Discharge

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:

1. 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. 2. 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.

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Key information

Conditions

Dementia Behavior Brain Diseases Central Nervous System Diseases Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Union Hospital Affiliated to Fujian Medical University

Fujian, Fuzhou, China

Location status: Recruiting

Location contact

Xiaozhen Fu

CONTACT

[email protected]

15160301901

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients

  • 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.

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.

Exclusion criteria

Patients

  • 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

  • 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.

Treatment and study plan

Dyadic personalized home-based activity program intervention

Behavioral
  • 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 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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Cognitive Function of Dementia Patients

    Time frame: Baseline and post-intervention (at the end of week 12)

    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

  2. Activities of Daily Living of Dementia Patients

    Time frame: Baseline and post-intervention (at the end of week 12)

    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.

  3. Apathy of Dementia Patients

    Time frame: Baseline and post-intervention (at the end of week 12)

    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

  4. Agitation of Dementia Patients

    Time frame: Baseline and post-intervention (at the end of week 12)

    Assessment using the Cohen-Mansfield Agitation Inventory (CMAI) yields scores ranging from 29 to 203, with higher scores indicating more severe agitated behaviors

  5. Quality of Life in Dementia

    Time frame: Baseline and post-intervention (at the end of week 12)

    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

  6. Caregiver Readiness for Hospital Discharge

    Time frame: Baseline（on the day of patient discharge）

    Assessment using the Caregiver Preparedness Scale (CPS) yields total scores ranging from 0 to 32, with higher scores indicating better discharge readiness.

  7. Caregiver Burden

    Time frame: Baseline and post-intervention (at the end of week 12)

    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.

  8. Self Efficacy of Caregivers

    Time frame: Baseline and post-intervention (at the end of week 12)

    Assessment using the General Self-Efficacy Scale (GSES) yields scores ranging from 10 to 40, with higher scores indicating greater self-efficacy

  9. Perceived Social Support of Caregivers

    Time frame: Baseline and post-intervention (at the end of week 12)

    Assessment using the Perceived Social Support Scale (PSSS) yields scores ranging from 12 to 84, with higher scores indicating greater perceived social support

  10. Depression of Dementia Patients

    Time frame: Baseline and post-intervention (at the end of week 12)

    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

  11. Depression of Caregivers

    Time frame: Baseline and post-intervention (at the end of week 12)

    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

  12. Anxiety of Dementia Patients

    Time frame: Baseline and post-intervention (at the end of week 12)

    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.

  13. Anxiety of Caregivers

    Time frame: Baseline and post-intervention (at the end of week 12)

    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.

  14. Family Quality of Life in Dementia

    Time frame: Baseline and post-intervention (at the end of week 12)

    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

  15. Family Adaptability and Cohesion in Dementia

    Time frame: Baseline and post-intervention (at the end of week 12)

    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

  16. Number of Participants with Intervention-Related Adverse Events

    Time frame: Post-intervention (at the end of week 12)

Other outcomes

  1. Number of caregivers with varying levels of satisfaction towards the intervention

    Time frame: Post-intervention (at the end of week 12)

  2. Number of dementia patients with varying levels of satisfaction towards the intervention

    Time frame: Post-intervention (at the end of week 12)

  3. Number of completed activity intervention sessions for dementia patients

    Time frame: Post-intervention (at the end of week 12)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaozhen Fu

CONTACT

[email protected]

15160301901

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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