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NCT Number: NCT06848036

Effectiveness of a Smart Community- and Home-based Integrated Care Services System for Elderly People

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Smart Community- and Home-based Integrated Care Services

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changsha County Guoyuan Town Health Center

Changsha, Hunan, 410157, China

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

smart integrated care services

Behavioral

Provide integrated care services through the 'Hunan Province Integrated Healthcare and Elderly Care Intelligent Service Platform,' including home-based care, mobile medical visits, and remote diagnosis and treatment services."

Primary outcomes

SF-36 scale (Short Form 36 Health Survey)

Time frame: Measurements were taken to obtain data after interventions at three months, six months, and twelve months.

The SF-36 (Short Form 36 Health Survey) is a tool used to assess health-related quality of life across 8 dimensions, each scored from 0 to 100. A higher score indicates better health. The 8 dimensions are:

Physical Functioning (PF): Ability to perform physical activities. Role-Physical (RP): Limitations due to physical health. Bodily Pain (BP): Pain intensity and impact. General Health (GH): Overall health perception. Vitality (VT): Energy levels and fatigue. Social Functioning (SF): Impact on social activities. Role-Emotional (RE): Limitations due to emotional problems. Mental Health (MH): Psychological well-being. Scores are calculated based on responses, with 0 representing the worst health and 100 the best. The higher the total score, the better the health.

Secondary outcomes

ADL scale（（Activity of Daily Living）

Time frame: Measurements were taken to obtain data after interventions at three months, six months, and twelve months.

ADL (Activities of Daily Living) is used to assess an individual's ability to perform basic activities of daily living, particularly self-care functions.The score for each option in the scale will be reported, with the minimum score for each option being 0 and the maximum score being 3. The scores will then be summed, with the total score having a minimum value of 0 and a maximum value of 20.Total possible scores range from 0 - 20, with lower scores indicating increased disability. If used to measure improvement after rehabilitation, changes of more than two points in the total score reflect a probable genuine change, and change on one item from fully dependent to independent is also likely to be reliable.
GDS scale（Geriatric Depression Scale)

Time frame: Measurements were taken to obtain data after interventions at three months, six months, and twelve months.

The GDS will evaluate the mental status of the elderly, using a questionnaire format.The GDS scale contains 15 items, and participants answer with "Yes" or "No." Each "Yes" is scored 1 point, and each "No" is scored 0 points. The total score is the sum of the individual item scores. A higher total score indicates more pronounced depressive symptoms. A score of ≥6 points suggests the presence of depressive mood, 0-5 points indicates no depressive mood, 6-9 points indicates mild depressive mood, and 10-12 points indicates severe depressive mood.

Sponsors and collaborators

Lead sponsor

Liu Zhihan

Other

Registry information

Official study 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

Acronym: ESCHIC

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Feb 26, 2025
Registry last updated: Feb 26, 2025

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.