FragilityNCT03528005
Effectiveness of Integrated Care Network
A study testing Multi-domain intervention in people with Fragility and Multimorbidity, run by National Yang Ming Chiao Tung University at 6 sites in Taiwan.
Trial summary
This project aims to examine the effectiveness of the community-based integrated care service model , based on a multi-domain intervention program, among community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fragility, Multimorbidity
- What is being tested?
- Multi-domain intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 6 sitesTaiwan
- Study dates
- 25 Jun 2018to 14 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age ≧ 65 years
- three or more chronic conditions, defined by National Health Insurance list of chronic conditions
- covered by National Health Insurance
Who cannot join
- could not understanding protocol or communication with research nurses
- malignant diseases under active treatments
- life expectancy less than twelve months
- admitted in the long term facility
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
Hualien City, 970
Shulin Primary Care center
New Taipei City, 238
Yingge Primary Health Care center
New Taipei City, 239
Cheng's primary care clinic
New Taipei City, 241
National Yang-Ming University Hospital
Yilan, 264
Taipei Veterans General Hospital Yuanshan Branch
Yilan, 264
About this study
Official title: Effectiveness of Integrated Care Network for Community-living Older Adults: a Randomized-Controlled Trial
This project aims to examine the effectiveness of the community-based integrated care service model , based on a multi-domain intervention program, among community-dwelling older adults. Moreover, the investigators use the value-based healthcare standard set as well as comprehensive geriatric assessment as outcome measures and to use the randomized controlled trial design to validate the clinical effectiveness.
Read the detailed description
Population aging and the progress of medical technology are two main causes for the increase of healthcare expenditure. Effective management of medical expenditure and maintenance of health care quality have become the most important task for the public health and clinical care services. Both United Kingdom and the World Health Organization proposed introducing interdisciplinary team care to improve health of older people and to maximize their independence. Prof Michael Porter has addressed the current difficulty of healthcare system, and proposed that healthcare system should pursuit long-term outcome to promote the value of health care. This project aims to echo the international trends, using Taiwan healthcare system as the basis to establish the community-based integrated care service model, and to use the randomized controlled trial design to validate the clinical effectiveness.
- Conditions
- Fragility, Multimorbidity
- Being tested
- Multi-domain intervention
- Keywords
- Integrated Health Care Systems, Multimorbid, Multi-domain intervention, Clinical Trials, Randomized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-domain interventionBehavioural
60 minutes cognitive training, 45 minutes physical exercise, 15 diet nutrition and intermittent disease management consultation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | A regular health education program was provided by case managers only. |
| Intervention | Experimental | Multi-domain intervention included exercise,cognitive training, diet education, and disease consultation was conducted for two hours twice per week in the first month, once per week in the second month, and once per month since third month. Receives: Behavioral: Multi-domain intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline life quality at 3, 6, 9, 12 month
measured by the 36-Item Short Form Health Survey (SF-36).
Measured: baseline, 3, 6, 9, 12 month
Secondary outcomes (1)
Changes from baseline standard set of health outcome measures for older persons at 3, 6, 9, 12 month
a standard health care set proposed by the International Consortium for Health Outcomes Measurement (ICHOM)
Measured: baseline, 3, 6, 9, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start25 Jun 2018
- Primary completion14 Mar 2020
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FragilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang-Kung Chen, National Yang Ming Chiao Tung University
- Investigators
- Liang-Kung Chen, MD.PhD., Study director, Aging and Health Research Center, National Yang Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528005
- Sponsor's protocol ID
- YM107042F
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2018
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee WJ, Peng LN, Lin MH, Kim S, Hsiao FY, Chen LK. Enhancing Intrinsic Capacity and Related Biomarkers in Community-Dwelling Multimorbid Older Adults Through Integrated Multidomain Interventions: Ancillary Findings From the Taiwan Integrated Geriatric (TIGER) Trial. J Am Med Dir Assoc. 2024 May;25(5):757-763.e4. doi: 10.1016/j.jamda.2023.10.006. Epub 2023 Nov 7.
PubMed 37949432Lee WJ, Peng LN, Lin CH, Chen RC, Lin SZ, Loh CH, Kao SL, Hung TS, Chang CY, Huang CF, Tang TC, Huang ST, Wen YW, Hsiao FY, Chen LK; Taiwan Integrated Geriatric Care Study Group. Effects of incorporating multidomain interventions into integrated primary care on quality of life: a randomised controlled trial. Lancet Healthy Longev. 2021 Nov;2(11):e712-e723. doi: 10.1016/S2666-7568(21)00248-8. Epub 2021 Oct 22.
PubMed 36098028
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Integrated Care Network for Community-living Older Adults: a Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT03528005
- Acronym / sponsor ID
- YM107042F
- Conditions
- Fragility, Multimorbidity
- Keywords
- Integrated Health Care Systems, Multimorbid, Multi-domain intervention, Clinical Trials, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 17 May 2018 (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.
This project aims to examine the effectiveness of the community-based integrated care service model , based on a multi-domain intervention program, among community-dwelling older adults. Moreover, the investigators use the value-based healthcare standard set as well as comprehensive geriatric assessment as outcome measures and to use the randomized controlled trial design to validate the clinical effectiveness.
Detailed description
Population aging and the progress of medical technology are two main causes for the increase of healthcare expenditure. Effective management of medical expenditure and maintenance of health care quality have become the most important task for the public health and clinical care services. Both United Kingdom and the World Health Organization proposed introducing interdisciplinary team care to improve health of older people and to maximize their independence. Prof Michael Porter has addressed the current difficulty of healthcare system, and proposed that healthcare system should pursuit long-term outcome to promote the value of health care. This project aims to echo the international trends, using Taiwan healthcare system as the basis to establish the community-based integrated care service model, and to use the randomized controlled trial design to validate the clinical effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –A regular health education program was provided by case managers only. |
| Intervention | Experimental | Behavioral: Multi-domain interventionMulti-domain intervention included exercise,cognitive training, diet education, and disease consultation was conducted for two hours twice per week in the first month, once per week in the second month, and once per month since third month. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age ≧ 65 years
- three or more chronic conditions, defined by National Health Insurance list of chronic conditions
- covered by National Health Insurance
Key exclusion criteria (4 listed)
- could not understanding protocol or communication with research nurses
- malignant diseases under active treatments
- life expectancy less than twelve months
- admitted in the long term facility
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 |
|---|---|---|
| Multi-domain intervention60 minutes cognitive training, 45 minutes physical exercise, 15 diet nutrition and intermittent disease management consultation | Behavioural | Intervention |
Primary outcome
Changes from baseline life quality at 3, 6, 9, 12 month
Time frame: baseline, 3, 6, 9, 12 month
measured by the 36-Item Short Form Health Survey (SF-36).
1 secondary outcome
Changes from baseline standard set of health outcome measures for older persons at 3, 6, 9, 12 month
Time frame: baseline, 3, 6, 9, 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Derived from this study: PubMed 37949432Lee WJ, Peng LN, Lin MH, Kim S, Hsiao FY, Chen LK. Enhancing Intrinsic Capacity and Related Biomarkers in Community-Dwelling Multimorbid Older Adults Through Integrated Multidomain Interventions: Ancillary Findings From the Taiwan Integrated Geriatric (TIGER) Trial. J Am Med Dir Assoc. 2024 May;25(5):757-763.e4. doi: 10.1016/j.jamda.2023.10.006. Epub 2023 Nov 7.
- Derived from this study: PubMed 36098028Lee WJ, Peng LN, Lin CH, Chen RC, Lin SZ, Loh CH, Kao SL, Hung TS, Chang CY, Huang CF, Tang TC, Huang ST, Wen YW, Hsiao FY, Chen LK; Taiwan Integrated Geriatric Care Study Group. Effects of incorporating multidomain interventions into integrated primary care on quality of life: a randomised controlled trial. Lancet Healthy Longev. 2021 Nov;2(11):e712-e723. doi: 10.1016/S2666-7568(21)00248-8. Epub 2021 Oct 22.
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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.
Liang-Kung Chen, MD.PhD. study director
Aging and Health Research Center, National Yang Ming University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-domain intervention in people with Fragility and Multimorbidity, run by National Yang Ming Chiao Tung University at 6 sites in Taiwan.
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 3 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: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from baseline life quality at 3, 6, 9, 12 month (time frame: baseline, 3, 6, 9, 12 month). 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 NCT03528005, which also lists 2 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 21 Apr 2020.