Physical DisabilityNCT02273934
The Effectiveness of Reablement in Home Dwelling Adults
A study testing Reablement and Standard treatment in people with Physical Disability, run by Frode F. Jacobsen at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether a special kind of rehabilitation offered to home-dwelling adults is effective with regards to functional ability, health-related quality of life, coping, mental health and municipal costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Disability
- What is being tested?
- Reablement and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2014to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Home-dwelling person
- Applicant of home-based services
- Above 18 years old
- Functional decline in at least one activity
- Able to understand written and oral Norwegian
Who cannot join
- Cognitive disability
- Terminal ill
- Being assessed as needing nursing home placement
- Being assessed as needing institution-based rehabilitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Reablement in Home Dwelling Adults. A Quasi Experimental Trial
The purpose of this study is to determine whether a special kind of rehabilitation offered to home-dwelling adults is effective with regards to functional ability, health-related quality of life, coping, mental health and municipal costs.
Read the detailed description
Health promotion and prevention of functional decline among home dwelling adults and immediate onset of rehabilitation, can improve function, and reduce or delay need for home-based assistance and institution placement. In the coming years there will be a significant increase in number of persons in Norway that need interventions aiming at coping with everyday activities. Therefore there is a call for new models for early intervention and rehabilitation in order to give service to a larger amount of home living people. Reablement is a new and promising rehabilitation model which many Norwegian municipalities are implementing in order to meet current and future needs for municipal home-based services. However, very little research has been performed regarding the effectiveness of this intervention. This study aims at assessing the effectiveness of reablement in terms of daily functioning, health-related quality of life, coping, mental health and economic municipal costs.
The study will be conducted in 44 municipalities in Norway. It is a quasi-experimental intervention trial, recruiting home-dwelling adults with an initial functional decline in daily activities. The intervention is intensive, multidisciplinary, home-based rehabilitation given by home-trainers, under supervision from an occupational therapist, nurse or a physiotherapist. The control intervention is standard home-based treatment and care.
A total of approximately 750 participants will be recruited, including approximately 100 participants the control group. The participants will be assessed at baseline, and at 10 weeks ,6-, and 12 months follow-up. Primary outcomes will be participation, activity, and municipal expenditures. Costs are generated by the working hours of the different professions. Hence, there will be a weekly registration of the working hours different health care professions spend in the private homes of the participants.
Data analyses will be performed according to intention to treat. Univariate analysis of covariance will be used to investigate differences between the groups from baseline to the end of intervention. The working hour data is panel data and will be analyzed accordingly; a random or a mixed effect regression model will be employed. Also, descriptive statistics and simpler tests will be carried out.
- Conditions
- Physical Disability
- Being tested
- Reablement, Standard treatment
- Keywords
- Home-based rehabilitation, Activities of daily living, Restorative care, Reablement, Everyday rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReablementBehavioural
Also called Hverdagsrehabilitering, Hemrehabilitering, Re-ablement, Restorative care
The intervention deals with improving function in daily activities the person defines as important in the areas of self-care, productivity and leisure.
Standard treatmentBehavioural
Also called Usual care, Treatment as usual
The control intervention is standard home-based treatment/care in Norway.
| Study group | Role | What they receive |
|---|---|---|
| Reablement | Experimental | Reablement is an intensive, multidisciplinary, client-centered, home-based type of rehabilitation, where ordinary activities of daily living are used for rehabilitative purposes. It is a rehabilitation alternative that may be offered to adults, and there is no lower age limit. An occupational therapist and physical therapist, or nurse, constitutes the key personal, while home helpers, assistants and others with lower education, are the ones who work rehabilitative with the person on a daily basis focusing on self-help. Receives: Behavioral: Reablement |
| Standard treatment | Active comparator | This arm consists of the standard treatment home-dwelling elderly persons receive when applying for home-based help. Some elderly may receive home-based nursing or home help services assisting them in daily activities, while others may receive occupational therapy or physical therapy measures for rehabilitative purposes. Receives: Behavioral: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score in Canadian Occupational Performance Measure
Activity and participation will be measured using Canadian Occupational Performance Measure (COPM) The COPM is a measure of a client's self-perception of occupational performance in the areas of self-care, productivity and leisure. Outcome measures for the COPM are: the client's most important problems in occupational performance and a total score of performance and a total score of satisfaction for these problems.
Measured: Baseline, 10 weeks, 6 months and 12 months
Secondary outcomes (2)
Expenditure
Municipal expenditures will be recorded weekly for six months. Costs will be recorded in accordance with the operating hours of the different health care professions in the private homes of the participants.
Measured: Weekly from baseline to 6 months
Short Physical Performance Battery
Short Physical Performance Battery (SPPB) investigates balance, walking function and muscle strength in the lower limbs.
Measured: Baseline, 10 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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 Physical DisabilityStudies 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
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frode F. Jacobsen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, University of Bergen
- Responsible party
- Sponsor-investigator, Frode F. Jacobsen, Bergen University College
- Investigators
- Frode Jacobsen, PhD, Study chair, Bergen University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273934
- Sponsor's protocol ID
- EL-123-REHAB
- Status last verified
- Jun 2015
- First submitted
- 29 Sep 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Langeland E, Tuntland H, Folkestad B, Forland O, Jacobsen FF, Kjeken I. A multicenter investigation of reablement in Norway: a clinical controlled trial. BMC Geriatr. 2019 Jan 30;19(1):29. doi: 10.1186/s12877-019-1038-x.
PubMed 30700255Langeland E, Tuntland H, Forland O, Aas E, Folkestad B, Jacobsen FF, Kjeken I. Study protocol for a multicenter investigation of reablement in Norway. BMC Geriatr. 2015 Sep 15;15:111. doi: 10.1186/s12877-015-0108-y.
PubMed 26374305
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Reablement in Home Dwelling Adults. A Quasi Experimental Trial
- ClinicalTrials.gov ID
- NCT02273934
- Acronym / sponsor ID
- EL-123-REHAB
- Conditions
- Physical Disability
- Keywords
- Home-based rehabilitation, Activities of daily living, Restorative care, Reablement, Everyday rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Frode F. JacobsenUniversity, hospital or other
- Collaborators
- University of Oslo, University of Bergen
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Oct 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 purpose of this study is to determine whether a special kind of rehabilitation offered to home-dwelling adults is effective with regards to functional ability, health-related quality of life, coping, mental health and municipal costs.
Detailed description
Health promotion and prevention of functional decline among home dwelling adults and immediate onset of rehabilitation, can improve function, and reduce or delay need for home-based assistance and institution placement. In the coming years there will be a significant increase in number of persons in Norway that need interventions aiming at coping with everyday activities. Therefore there is a call for new models for early intervention and rehabilitation in order to give service to a larger amount of home living people. Reablement is a new and promising rehabilitation model which many Norwegian municipalities are implementing in order to meet current and future needs for municipal home-based services. However, very little research has been performed regarding the effectiveness of this intervention. This study aims at assessing the effectiveness of reablement in terms of daily functioning, health-related quality of life, coping, mental health and economic municipal costs.
The study will be conducted in 44 municipalities in Norway. It is a quasi-experimental intervention trial, recruiting home-dwelling adults with an initial functional decline in daily activities. The intervention is intensive, multidisciplinary, home-based rehabilitation given by home-trainers, under supervision from an occupational therapist, nurse or a physiotherapist. The control intervention is standard home-based treatment and care.
A total of approximately 750 participants will be recruited, including approximately 100 participants the control group. The participants will be assessed at baseline, and at 10 weeks ,6-, and 12 months follow-up. Primary outcomes will be participation, activity, and municipal expenditures. Costs are generated by the working hours of the different professions. Hence, there will be a weekly registration of the working hours different health care professions spend in the private homes of the participants.
Data analyses will be performed according to intention to treat. Univariate analysis of covariance will be used to investigate differences between the groups from baseline to the end of intervention. The working hour data is panel data and will be analyzed accordingly; a random or a mixed effect regression model will be employed. Also, descriptive statistics and simpler tests will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reablement | Experimental | Behavioral: ReablementReablement is an intensive, multidisciplinary, client-centered, home-based type of rehabilitation, where ordinary activities of daily living are used for rehabilitative purposes. It is a rehabilitation alternative that may be offered to adults, and there is no lower age limit. An occupational therapist and physical therapist, or nurse, constitutes the key personal, while home helpers, assistants and others with lower education, are the ones who work rehabilitative with the person on a daily basis focusing on self-help. |
| Standard treatment | Active comparator | Behavioral: Standard treatmentThis arm consists of the standard treatment home-dwelling elderly persons receive when applying for home-based help. Some elderly may receive home-based nursing or home help services assisting them in daily activities, while others may receive occupational therapy or physical therapy measures for rehabilitative purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Home-dwelling person
- Applicant of home-based services
- Above 18 years old
- Functional decline in at least one activity
- Able to understand written and oral Norwegian
Key exclusion criteria (4 listed)
- Cognitive disability
- Terminal ill
- Being assessed as needing nursing home placement
- Being assessed as needing institution-based rehabilitation
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 |
|---|---|---|
| ReablementAlso: Hverdagsrehabilitering, Hemrehabilitering, Re-ablement, Restorative careThe intervention deals with improving function in daily activities the person defines as important in the areas of self-care, productivity and leisure. | Behavioural | Reablement |
| Standard treatmentAlso: Usual care, Treatment as usualThe control intervention is standard home-based treatment/care in Norway. | Behavioural | Standard treatment |
Primary outcome
Change in score in Canadian Occupational Performance Measure
Time frame: Baseline, 10 weeks, 6 months and 12 months
Activity and participation will be measured using Canadian Occupational Performance Measure (COPM) The COPM is a measure of a client's self-perception of occupational performance in the areas of self-care, productivity and leisure. Outcome measures for the COPM are: the client's most important problems in occupational performance and a total score of performance and a total score of satisfaction for these problems.
2 secondary outcomes
Expenditure
Time frame: Weekly from baseline to 6 months
Short Physical Performance Battery
Time frame: Baseline, 10 weeks, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Derived from this study: PubMed 30700255Langeland E, Tuntland H, Folkestad B, Forland O, Jacobsen FF, Kjeken I. A multicenter investigation of reablement in Norway: a clinical controlled trial. BMC Geriatr. 2019 Jan 30;19(1):29. doi: 10.1186/s12877-019-1038-x.
- Derived from this study: PubMed 26374305Langeland E, Tuntland H, Forland O, Aas E, Folkestad B, Jacobsen FF, Kjeken I. Study protocol for a multicenter investigation of reablement in Norway. BMC Geriatr. 2015 Sep 15;15:111. doi: 10.1186/s12877-015-0108-y.
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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.
Frode Jacobsen, PhD study chair
Bergen University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reablement and Standard treatment in people with Physical Disability, run by Frode F. Jacobsen at 1 site in Norway.
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: status not confirmed, as of the sponsor's last update on 18 Nov 2015. 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 Norway. 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?
Results are not available in the source record.
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 score in Canadian Occupational Performance Measure (time frame: Baseline, 10 weeks, 6 months and 12 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 NCT02273934, 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 18 Nov 2015.