Mobility LimitationNCT02298374
Evaluation of Homecare Reablement, the Trondheim Model
A study testing Homecare reablement in people with Mobility Limitation and Asthenia, run by Norwegian University of Science and Technology.
Trial summary
The aim is to evaluate a model of home-based rehabilitation. The intervention targets elder persons who receive homecare services, but still are relatively independent in most activities of daily living. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mobility Limitation, Asthenia
- What is being tested?
- Homecare reablement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jun 2017
- 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
- receive homecare services
- live within the catchment area
Who cannot join
- In-patient length of stay (IPLOS) score > 2.0
- severe dementia
About this study
The aim is to evaluate a model of home-based rehabilitation. The intervention targets elder persons who receive homecare services, but still are relatively independent in most activities of daily living. The model focuses on early identification of decline in function and intervention in the home environment through close cooperation between the participant, homecare services and therapists.
- Conditions
- Mobility Limitation, Asthenia
- Being tested
- Homecare reablement, usual care
- Keywords
- Rehabilitation, Evaluation studies, Home care services
- Medical subject headings
- Mobility Limitation, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homecare reablementOther
usual careOther
| Study group | Role | What they receive |
|---|---|---|
| Homecare reablement | Experimental | Receives comprehensive assessment and individualized follow-up according to a plan with short and longterm goals. Receives: Other: Homecare reablement |
| Usual care | Active comparator | Receives normal care Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Activity level (measured by body-worn sensors)
measured by body-worn sensors over 4 days
Measured: 1 years
Secondary outcomes (5)
Change in Short Physical performance battery score
Performance based test of lower extremity function
Measured: 1 year
Change in received hours with homecare services
Including nursing, assistance in activities of daily living and domestic work
Measured: 1 year
Qualys (EQ- 5D)
EQ- 5D
Measured: 1 year
Change in IPLOS score
A composite score on level of dependency in 17 different areas related to activities of daily living, including cognitive function
Measured: one year
Change in cognitive function (Subscore of the Iplos score)
Subscore of the Iplos score
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Trondheim Kommune, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Jorunn L Helbostad, phd prof, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298374
- Sponsor's protocol ID
- 2014/436
- Status last verified
- Apr 2017
- First submitted
- 3 Oct 2014
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Homecare Reablement, the Trondheim Model
- ClinicalTrials.gov ID
- NCT02298374
- Acronym / sponsor ID
- 2014/436
- Conditions
- Mobility Limitation, Asthenia
- Keywords
- Rehabilitation, Evaluation studies, Home care services
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Trondheim Kommune, St. Olavs Hospital
- Study start
- Nov 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Nov 2014 (estimated)
- 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.
The aim is to evaluate a model of home-based rehabilitation. The intervention targets elder persons who receive homecare services, but still are relatively independent in most activities of daily living. The model focuses on early identification of decline in function and intervention in the home environment through close cooperation between the participant, homecare services and therapists.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homecare reablement | Experimental | Other: Homecare reablementReceives comprehensive assessment and individualized follow-up according to a plan with short and longterm goals. |
| Usual care | Active comparator | Other: usual careReceives normal care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- receive homecare services
- live within the catchment area
Key exclusion criteria (2 listed)
- In-patient length of stay (IPLOS) score > 2.0
- severe dementia
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 |
|---|---|---|
| Homecare reablement | Other | Homecare reablement |
| usual care | Other | Usual care |
Primary outcome
Change in Activity level (measured by body-worn sensors)
Time frame: 1 years
measured by body-worn sensors over 4 days
5 secondary outcomes
Change in Short Physical performance battery score
Time frame: 1 year
Change in received hours with homecare services
Time frame: 1 year
Qualys (EQ- 5D)
Time frame: 1 year
Change in IPLOS score
Time frame: one year
Change in cognitive function (Subscore of the Iplos score)
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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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.
Jorunn L Helbostad, phd prof principal investigator
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Homecare reablement in people with Mobility Limitation and Asthenia, run by Norwegian University of Science and Technology.
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 2 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: withdrawn, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 Activity level (measured by body-worn sensors) (time frame: 1 years). 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 21 Apr 2017.