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

ConditionDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorFujian Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dyadic personalized home-based activity program intervention

    Behavioral

    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.

  • Routine care

    Other intervention

    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.

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: Dyadic personalized home-based activity program interventionExperimental treatment 1 intervention
Group B: Routine careOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and post-intervention (at the end of week 12)
2

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

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

Secondary outcomes

1

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

Time frame
Baseline and post-intervention (at the end of week 12)
2

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.

Time frame
Baseline and post-intervention (at the end of week 12)
3

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

Time frame
Baseline and post-intervention (at the end of week 12)
4

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

Time frame
Baseline and 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)

Sponsors and contacts

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