Long Term CareNCT04311138
Effect of Community-based Reablement
A study testing community-based reablement service and multicomponent training in people with Long Term Care, run by CY Song at 1 site in Taiwan.
Trial summary
This study aims o investigate the effect of a diversified community-based reablement on motor function, cognitive function, performance in activities of daily living (ADL), and physical performance of older people living in remote areas. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Long Term Care
- What is being tested?
- community-based reablement service and multicomponent training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Sep 2019to 29 Nov 2019
- 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
- living in community and participating in public elderly day care centers in remote areas of the New Taipei City
- speaking with Chinese or Taiwanese
- DEMMI score of 39-67
Who cannot join
- diagnosed with moderate or severe cognitive impairment (CDR score of 2 or above)
- unable to understand or follow one step instruction
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taipei University of Nursing and Health Sciences
Taipei, 11219
About this study
Official title: The Effect of Community-based Reablement in Remote Areas
This study aims o investigate the effect of a diversified community-based reablement on motor function, cognitive function, performance in activities of daily living (ADL), and physical performance of older people living in remote areas. Older adults who are mobile but unstable were recruited from 6 public elderly day care centers in remote areas of the New Taipei City. Experimental group received a 10-wk diversified community-based reablement service including group exercise, cognitive training, health education for 1.5 hours, and individualized reablement for 1.0 hour, while control group received 1.5-hr group intervention and 1.0-hr placebo intervention. The de Morton Mobility Index (DEMMI), Saint Louis Mental Status Examination (SLUMS), Barthel Index (BI), Canadian Occupational Performance Measure (COPM), and the Short Physical Performance Battery (SPPB) including balance, gait speed, chair stand tests were evaluated twice before and after interventions. The results of the current study are expected to provide evidence in supporting a novel and diversified community-based reablement in remote areas.
- Conditions
- Long Term Care
- Being tested
- community-based reablement service, multicomponent training
- Keywords
- reablement, community
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community-based reablement serviceOther
Experimental group receive a 10-wk diversified community-based reablement service including group exercise, cognitive training, health education for 1.5 hours, and individualized reablement for 1.0 hour.
multicomponent trainingOther
control group receive a 10-wk multicomponent training including 1.5-hr group intervention (group exercise, cognitive training, and health education) and 1.0-hr placebo intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group receive a 10-wk diversified community-based reablement service. Receives: Other: community-based reablement service |
| Control group | Active comparator | Control group receive a 10-wk multicomponent training. Receives: Other: multicomponent training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mobility function
de Morton Mobility Index (DEMMI)
Measured: baseline and 10 weeks
Change in cognitive function
Saint Louis Mental Status Examination (SLUMS)
Measured: baseline and 10 weeks
Change in performance in activities of daily living
Barthel Index (BI)
Measured: baseline and 10 weeks
Change in occupational performance
Canadian Occupational Performance Measure (COPM)
Measured: baseline and 10 weeks
Change in physical performance
Short Physical Performance Battery (SPPB)
Measured: baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start3 Sep 2019
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term CareStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- CY Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CY Song, National Taipei University of Nursing and Health Sciences
- Investigators
- ChenYi Song, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311138
- Sponsor's protocol ID
- 19-060-B
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Community-based Reablement in Remote Areas
- ClinicalTrials.gov ID
- NCT04311138
- Acronym / sponsor ID
- 19-060-B
- Conditions
- Long Term Care
- Keywords
- reablement, community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CY SongUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 17 Mar 2020 (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 study aims o investigate the effect of a diversified community-based reablement on motor function, cognitive function, performance in activities of daily living (ADL), and physical performance of older people living in remote areas. Older adults who are mobile but unstable were recruited from 6 public elderly day care centers in remote areas of the New Taipei City. Experimental group received a 10-wk diversified community-based reablement service including group exercise, cognitive training, health education for 1.5 hours, and individualized reablement for 1.0 hour, while control group received 1.5-hr group intervention and 1.0-hr placebo intervention. The de Morton Mobility Index (DEMMI), Saint Louis Mental Status Examination (SLUMS), Barthel Index (BI), Canadian Occupational Performance Measure (COPM), and the Short Physical Performance Battery (SPPB) including balance, gait speed, chair stand tests were evaluated twice before and after interventions. The results of the current study are expected to provide evidence in supporting a novel and diversified community-based reablement in remote areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: community-based reablement serviceExperimental group receive a 10-wk diversified community-based reablement service. |
| Control group | Active comparator | Other: multicomponent trainingControl group receive a 10-wk multicomponent training. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- living in community and participating in public elderly day care centers in remote areas of the New Taipei City
- speaking with Chinese or Taiwanese
- DEMMI score of 39-67
Key exclusion criteria (2 listed)
- diagnosed with moderate or severe cognitive impairment (CDR score of 2 or above)
- unable to understand or follow one step instruction
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 |
|---|---|---|
| community-based reablement serviceExperimental group receive a 10-wk diversified community-based reablement service including group exercise, cognitive training, health education for 1.5 hours, and individualized reablement for 1.0 hour. | Other | Experimental group |
| multicomponent trainingcontrol group receive a 10-wk multicomponent training including 1.5-hr group intervention (group exercise, cognitive training, and health education) and 1.0-hr placebo intervention. | Other | Control group |
Primary outcome
Change in mobility function
Time frame: baseline and 10 weeks
de Morton Mobility Index (DEMMI)
Change in cognitive function
Time frame: baseline and 10 weeks
Saint Louis Mental Status Examination (SLUMS)
Change in performance in activities of daily living
Time frame: baseline and 10 weeks
Barthel Index (BI)
Change in occupational performance
Time frame: baseline and 10 weeks
Canadian Occupational Performance Measure (COPM)
Change in physical performance
Time frame: baseline and 10 weeks
Short Physical Performance Battery (SPPB)
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 17 Mar 2020.
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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.
ChenYi Song principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community-based reablement service and multicomponent training in people with Long Term Care, run by CY Song at 1 site 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 2 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 17 Mar 2020. 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 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?
Change in mobility function (time frame: baseline and 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2020.