Physical DisabilityNCT02043262
The Effectiveness of Reablement in Home Dwelling Older Adults. A Randomized Controlled Trial
A study testing Reablement and Standard treatment in people with Physical Disability, run by Frode F. Jacobsen at 2 sites in Norway.
Trial summary
The purpose of this study is to determine whether a special kind of rehabilitation offered to home-dwelling older adults is effective with regards to functional ability 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
- 61 participants
- Where
- 2 sitesNorway
- Study dates
- May 2012to Jun 2016
- 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
2 sites in 1 country.
Norway2 sites
Bergen University College
Bergen, 5009
Municpality of Voss
Bergen, 5701
About this study
Official title: Evaluating Reablement for Home-dwelling Elderly in a Norwegian Municipality
The purpose of this study is to determine whether a special kind of rehabilitation offered to home-dwelling older adults is effective with regards to functional ability and municipal costs.
Read the detailed description
Early detection of functional decline among home dwelling older adults and immediate onset of rehabilitation, can improve function, and reduce or delay need for home-based assistance and nursing home placement. Towards year 2050 there will be a significant increase in number of elderly persons in Norway, with an urgent need for new models for early intervention and rehabilitation in order to give service to a larger amount of elderly persons. 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 conducted regarding the effectiveness of this intervention. This study aims at assessing the effectiveness of reablement in terms of daily functioning and economic costs compared to standard home-based treatment and care.
The study will be conducted in the municipality of Voss in Western Norway, a municipality with only 14000 inhabitants. It is a double-blinded, block-randomized controlled intervention trial, recruiting home-dwelling older 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 or a physiotherapist. The control intervention is standard home-based treatment and care.
Thirty participants will be recruited in each arm of the study. The participants will be assessed at baseline, and at 3-, and 9 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 daily registration of the working hours different health care professions spend in the private homes of the participants.
Power calculations based on study with a similar target group using the instrument Canadian Occupational Performance Measure, estimate a need for only 21 participants in each group due to the longitudinal design. However, in order to account for possibilities of frailer target group or a large drop out rate (40 %), a total number of 30 participants in each group will be tried recruited. Data analyses will be performed according to intention to treat. 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
- Elderly, 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 older adults, although 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 older 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.
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
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.
Measured: 3 months
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.
Measured: 9 months
Secondary outcomes (2)
Expenditure
Municipal expenditures will be recorded daily for nine months. Costs will be recorded in accordance with the operating hours of the different health care professions in the private homes of the participants. The control group will be assessed for amount of municipal home-based help at 15 months follow-up.
Measured: Daily from baseline to 9 months.
Expenditure
The control group will be assessed for amount of municipal home-based help at 15 months follow-up.
Measured: 15 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startMay 2012
- Primary completionJun 2015
- Study completionJun 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frode F. Jacobsen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Diakonhjemmet Hospital
- Responsible party
- Sponsor-investigator, Frode F. Jacobsen, Bergen University College
- Investigators
- Frode Fa Jacobsen, PhD, Study chair, Bergen University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043262
- Sponsor's protocol ID
- 2012/295
- Status last verified
- Jun 2016
- First submitted
- 20 Nov 2012
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tuntland H, Aaslund MK, Espehaug B, Forland O, Kjeken I. Reablement in community-dwelling older adults: a randomised controlled trial. BMC Geriatr. 2015 Nov 4;15:145. doi: 10.1186/s12877-015-0142-9.
PubMed 26537789Tuntland H, Espehaug B, Forland O, Hole AD, Kjerstad E, Kjeken I. Reablement in community-dwelling adults: study protocol for a randomised controlled trial. BMC Geriatr. 2014 Dec 18;14:139. doi: 10.1186/1471-2318-14-139.
PubMed 25519828
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Reablement for Home-dwelling Elderly in a Norwegian Municipality
- ClinicalTrials.gov ID
- NCT02043262
- Acronym / sponsor ID
- 2012/295
- Conditions
- Physical Disability
- Keywords
- Elderly, Home-based rehabilitation, Activities of daily living, Restorative care, Reablement, Everyday rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Frode F. JacobsenUniversity, hospital or other
- Collaborators
- University of Bergen, Diakonhjemmet Hospital
- Study start
- May 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Jan 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 older adults is effective with regards to functional ability and municipal costs.
Detailed description
Early detection of functional decline among home dwelling older adults and immediate onset of rehabilitation, can improve function, and reduce or delay need for home-based assistance and nursing home placement. Towards year 2050 there will be a significant increase in number of elderly persons in Norway, with an urgent need for new models for early intervention and rehabilitation in order to give service to a larger amount of elderly persons. 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 conducted regarding the effectiveness of this intervention. This study aims at assessing the effectiveness of reablement in terms of daily functioning and economic costs compared to standard home-based treatment and care.
The study will be conducted in the municipality of Voss in Western Norway, a municipality with only 14000 inhabitants. It is a double-blinded, block-randomized controlled intervention trial, recruiting home-dwelling older 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 or a physiotherapist. The control intervention is standard home-based treatment and care.
Thirty participants will be recruited in each arm of the study. The participants will be assessed at baseline, and at 3-, and 9 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 daily registration of the working hours different health care professions spend in the private homes of the participants.
Power calculations based on study with a similar target group using the instrument Canadian Occupational Performance Measure, estimate a need for only 21 participants in each group due to the longitudinal design. However, in order to account for possibilities of frailer target group or a large drop out rate (40 %), a total number of 30 participants in each group will be tried recruited. Data analyses will be performed according to intention to treat. 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- 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 older adults, although 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 older 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
Canadian Occupational Performance Measure
Time frame: Baseline
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.
Canadian Occupational Performance Measure
Time frame: 3 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.
Canadian Occupational Performance Measure
Time frame: 9 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.
2 secondary outcomes
Expenditure
Time frame: Daily from baseline to 9 months.
Expenditure
Time frame: 15 months follow-up
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 3 Jun 2016.
- Derived from this study: PubMed 26537789Tuntland H, Aaslund MK, Espehaug B, Forland O, Kjeken I. Reablement in community-dwelling older adults: a randomised controlled trial. BMC Geriatr. 2015 Nov 4;15:145. doi: 10.1186/s12877-015-0142-9.
- Derived from this study: PubMed 25519828Tuntland H, Espehaug B, Forland O, Hole AD, Kjerstad E, Kjeken I. Reablement in community-dwelling adults: study protocol for a randomised controlled trial. BMC Geriatr. 2014 Dec 18;14:139. doi: 10.1186/1471-2318-14-139.
- Published randomised controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Fa Jacobsen, PhD study chair
Bergen University College
2 sites 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 2 sites 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: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Canadian Occupational Performance Measure (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT02043262, 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 3 Jun 2016.