Smart Community- and Home-based Integrated Care ServicesESCHICNCT06848036
Effectiveness of a Smart Community- and Home-based Integrated Care Services System for Elderly People
A study testing smart integrated care services in people with Smart Community- and Home-based Integrated Care Services, run by Liu Zhihan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smart Community- and Home-based Integrated Care Services
- What is being tested?
- smart integrated care services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2024to Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed description
- 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)
- Being tested
- smart integrated care services
- Keywords
- Integrated Care Services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart integrated care servicesBehavioural
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."
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Receiving integrated care services through the "Hunan Province Medical Elderly Integration Intelligent Service Platform". Receives: Behavioral: smart integrated care services |
| Control group | No intervention | Receive regular community care services, with no intervention, as a blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 scale (Short Form 36 Health Survey)
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.
Measured: Measurements were taken to obtain data after interventions at three months, six months, and twelve months.
Secondary outcomes (2)
ADL scale（（Activity of Daily Living）
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.
Measured: Measurements were taken to obtain data after interventions at three months, six months, and twelve months.
GDS scale（Geriatric Depression Scale)
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.
Measured: Measurements were taken to obtain data after interventions at three months, six months, and twelve months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start7 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Smart Community- and Home-based Integrated Care ServicesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liu Zhihan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Zhihan, Central South University
- Investigators
- Zhihan Liu, Principal investigator, School of Public Administration, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848036
- Sponsor's protocol ID
- 234083
- Other IDs
- Self-funded
- Acronym
- ESCHIC
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36429594Liu 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.
PubMed 39711744Wang 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.
PubMed 37427265Zhang 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.
PubMed 36901645
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06848036
- Acronym / sponsor ID
- ESCHIC / 234083
- Keywords
- Integrated Care Services
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Liu ZhihanUniversity, hospital or other
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 26 Feb 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.
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
- 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)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: smart integrated care servicesReceiving integrated care services through the "Hunan Province Medical Elderly Integration Intelligent Service Platform". |
| Control group | No intervention | –Receive regular community care services, with no intervention, as a blank control |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| smart integrated care servicesProvide 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." | Behavioural | Experimental group |
Primary outcome
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.
2 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.
GDS scale（Geriatric Depression Scale)
Time frame: Measurements were taken to obtain data after interventions at three months, six months, and twelve months.
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 26 Feb 2025.
- Background: PubMed 36429594Wang 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.
- Background: PubMed 39711744Liu 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.
- Background: PubMed 37427265Wang 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.
- Background: PubMed 36901645Zhang 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.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Zhihan Liu principal investigator
School of Public Administration, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smart integrated care services in people with Smart Community- and Home-based Integrated Care Services, run by Liu Zhihan 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06848036, which also lists 4 linked publications.
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 26 Feb 2025.