Clinical trial NCT06848036: Effectiveness of a Smart Community- and Home-based Integrated Care Services System for Elderly People
Official title: Effectiveness of a Smart Community- and Home-based Integrated Care Services System for Elderly People in Rural Chinese Communities: A Randomized Controlled Trial in Changsha County
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smart Community- and Home-based Integrated Care Services
Keywords: Integrated Care Services
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In recent years, the widespread application of emerging information technologies such as artificial intelligence, the Internet of Things, big data, cloud computing, and 5G has made "smart " a new breakthrough in the integrated healthcare and elderly care model. Smart Community- and Home-based Integrated Care Services , utilizing methods such as home hospital beds and mobile medical visits, ensure that key elderly groups with disabilities, dementia, chronic diseases, advanced age, and disabilities can receive the necessary medical services at home. This not only allows the elderly to live in familiar home environments, maintaining their independence and dignity, but also alleviates the pressure on medical resources, enabling more resources to be allocated to emergency care and highly specialized nursing. However, the smart healthcare and elderly care platform model is still in the pilot stage and requires more scientific evidence to verify its actual impact on the health of the elderly.

The purpose： The purpose of this clinical trial is to understand and verify the potential health improvement effects of the smart healthcare and elderly care platform on the elderly. By collecting health indicator data at different time points before and after the intervention, the study will compare the differences in health indicators between community-dwelling elderly who have used the smart healthcare and elderly care platform and those who have not, providing scientific evidence for the promotion of the smart healthcare and elderly care platform model and further facilitating its application and popularization among the elderly in the community.

The main question it aims to answer is: Are community-dwelling elderly who use the smart healthcare and elderly care platform healthier than those who do not use the service? Participants will： Participants will be randomly divided into an experimental group and a control group. The elderly in the experimental group will use the "Hunan Province Integrated Healthcare and Elderly Care Intelligent Service Platform," while the control group will not use the platform for blank control.

Data collection： The research team will collect health indicator data four times, including SF-36, Activities of Daily Living (ADL), and the Geriatric Depression Scale (GDS), at baseline, 3 months post-intervention, 6 months post-intervention, and 12 months post-intervention.

Detailed description: I. Recruitment Phase:

The study will recruit participants from Guoyuan Town, Changsha County. Eligible elderly individuals from rural communities will undergo qualification assessment based on inclusion/exclusion criteria. Accounting for a 20% attrition rate, the study plans to enroll 64 elderly participants from rural communities in Guoyuan Town.

II. Intervention Allocation Phase:

Participants will be randomly assigned to either the experimental or control group using computer-generated randomization. Baseline measurements will be collected using:

SF-36 Health Survey

Activities of Daily Living (ADL) scale

Geriatric Depression Scale (GDS)

The experimental group will receive integrated care services through the "Hunan Province Integrated Smart Healthcare and Elderly Care Service Platform", while the control group will receive standard community care. The intervention includes:

Educational seminars introducing "Hunan Province Integrated Smart Healthcare and Elderly Care Service Platform" services

Assistance with platform registration for experimental group participants

Implementation of integrated care services via the platform

III. Follow-up Phase:

Three follow-up assessments will be conducted at:

3 months post-intervention

6 months post-intervention

12 months post-intervention

Follow-up assessments will repeat baseline measurements (SF-36, ADL, GDS) to evaluate health status changes. Participant attrition will be documented through follow-up tracking. All data will undergo double-entry verification using two independent data clerks maintaining separate files, with regular cross-verification and final reconciliation after the last follow-up.

IV. Analysis Phase:

Statistical comparisons between groups will be performed using:

Independent t-tests

Analysis of variance (ANOVA)

Eligibility criteria: Inclusion Criteria:

1. Participants aged ≥60 years
2. Normal verbal communication abilities
3. No self-reported visual or auditory impairments
4. Presence of a long-term, fixed caregiver who accompanies and lives with the participant
5. Both the participant and their family members are informed and consent voluntarily to participate in this study

Exclusion Criteria

1. Participants aged \<60 years
2. Individuals suffering from severe physical or mental illnesses
3. Elderly individuals who have participated in other similar studies within the past year
4. Elderly individuals residing in institutions

Primary outcomes:
measure: SF-36 scale (Short Form 36 Health Survey)
timeFrame: Measurements were taken to obtain data after interventions at three months, six months, and twelve months.
Secondary outcomes:
measure: ADL scale（（Activity of Daily Living）
timeFrame: Measurements were taken to obtain data after interventions at three months, six months, and twelve months.
measure: GDS scale（Geriatric Depression Scale)
timeFrame: Measurements were taken to obtain data after interventions at three months, six months, and twelve months.
Other outcomes:
Locations:
city: Changsha
country: China
facility: Changsha County Guoyuan Town Health Center
state: Hunan
Study officials:
affiliation: School of Public Administration, Central South University
name: Zhihan Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Z, Wei H, Liu Z. Older Adults' Demand for Community-Based Adult Services (CBAS) Integrated with Medical Care and Its Influencing Factors: A Pilot Qualitative Study in China. Int J Environ Res Public Health. 2022 Nov 11;19(22):14869. doi: 10.3390/ijerph192214869.
citation: Liu Z, Ouyang C, Gu N, Zhang J, He X, Feng Q, Chang C. Service quality evaluation of integrated health and social care for older Chinese adults in residential settings based on factor analysis and machine learning. Digit Health. 2024 Dec 19;10:20552076241305705. doi: 10.1177/20552076241305705. eCollection 2024 Jan-Dec.
citation: Wang Z, Liu Z. Latent classes and related predictors of demand for home-and community-based integrated care for older Chinese adults. Front Public Health. 2023 Jun 23;11:1109981. doi: 10.3389/fpubh.2023.1109981. eCollection 2023.
citation: Zhang W, He X, Liu Z. Factors and Mechanism Influencing Client Experience of Residential Integrated Health and Social Care for Older People: A Qualitative Model in Chinese Institutional Settings. Int J Environ Res Public Health. 2023 Mar 6;20(5):4638. doi: 10.3390/ijerph20054638.