Activities of Daily LivingFORMASEvidNCT01960582
Evaluation of Housing Adaptations and Mobility Devices
A study testing New Practice Strategy in people with Activities of Daily Living and Cost Effectiveness, run by Lund University at 1 site in Sweden.
Trial summary
The rationale underlying this project is the fact that HA is a very common compensatory interven¬tion within municipality health care, undertaken to support an independent living in the own home. In addition, MD are frequently prescribed and used among HA clients in order to compensate for declined body functions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Activities of Daily Living, Cost Effectiveness, Housing
- What is being tested?
- New Practice Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteSweden
- Study dates
- 11 Jan 2013to 30 Apr 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons receiving housing adaptation
- Above 20 years
Who cannot join
- Persons with language deficits and/or cognitive decline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Housing Adaptations and Mobility Devices - Evaluation of a New Practice Strategy
The rationale underlying this project is the fact that HA is a very common compensatory interven¬tion within municipality health care, undertaken to support an independent living in the own home. In addition, MD are frequently prescribed and used among HA clients in order to compensate for declined body functions. In spite of this, knowledge of their effects for the individual and the society is still scarce. In particular, systematic, evidence-based strategies based on clear-cut conceptual definitions and descriptions of procedures are lacking. Such strategies are crucial in order to evaluate the effects of HA and MD. In addition, longterm cost-effectiveness evaluations are crucial for policy implementation.
The overarching aim is to investigate outcomes of HA on aspects of home and health for sub-groups of persons with disabilities.
Read more
The specific aims are to:
- Investigate the effects of HA on home and health related outcomes, i.e. usability, fear of falling, activity/participation and health-related quality of life for different subgroups of persons, e.g. MD users and non MD-users
- Investigate the use of a new practice strategy for HA on home and health related outcomes for subgroups of persons with disabilities in terms of differences between municipalities
- Investigate societal level outcomes of HA and MD, i.e. costs and quality adjusted life years
- Gain a deeper understanding of the processes behind changes in outcomes We hypothesise that using a structure strategy for housing adaptation and mobility devices case management in ordinary practice in Swedish municipalities increase activity, participation, the usability of the home, and reduces societal costs.
Read the detailed description
The ultimate goal of the project is to improve the housing situation of older people and people with disabilities, by determining the long term effects of housing adaptations (HA) for clients and society, and transferring this knowledge into guidelines for practitioners in the housing and building planning sector.
Specific research questions are:
RQ1. What are the long-term effects of HA for clients (individual goals achievement, activity, participation, health-related quality of life, usability, falls, functional capacity and use of mobility devices (MD), mortality, health care and social services consumption, and relocation)? RQ2. What are the long-term effects of HA for society (costs and cost- effectiveness)? RQ3. What are the barriers and facilitators to knowledge transfer in the area of HA? RQ4. How can evidence based knowledge be transferred into practical guidelines for housing and building planning in Sweden?
- Conditions
- Activities of Daily Living, Cost Effectiveness, Housing
- Being tested
- New Practice Strategy
- Keywords
- Housing adaptation, Independence, Costs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Practice StrategyBehavioural
Application of a structured case management strategy on housing adaptation cases
| Study group | Role | What they receive |
|---|---|---|
| New Practice Strategy | Experimental | Structured strategy for assessment and evaluation before and after intervention Receives: Behavioral: New Practice Strategy |
| Ordinary practice | No intervention | Ordinary practice, not structured |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADL Staircase
The ADL Staircase measures dependence on other persons in daily activities. Combined interview and observation
Measured: Differences in changes between intervention and control sites at baseline and 3, 6,12, 24 and 36 months after
Secondary outcomes (1)
Falls Efficacy Scale- FES-I
FES-I measures perceived fear of falling
Measured: Differences in changes between intervention and control sites at baseline and 3, 6, 12, 24 and 36 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study start11 Jan 2013
- Primary completion30 Apr 2020
- Study completion30 Apr 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 Activities of Daily LivingStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agneta Malmgren Fänge, Lund University
- Investigators
- Agneta M Fänge, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960582
- Sponsor's protocol ID
- FORMAS 2011-907
- Acronym
- FORMASEvid
- Status last verified
- Oct 2020
- First submitted
- 27 Sep 2013
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Malmgren Fange A, Carlsson G, Axmon A, Thordardottir B, Chiatti C, Nilsson MH, Ekstam L. Effects of applying a standardized assessment and evaluation protocol in housing adaptation implementation - results from a quasi-experimental study. BMC Public Health. 2019 Nov 4;19(1):1446. doi: 10.1186/s12889-019-7815-9.
PubMed 31684916Ekstam L, Carlsson G, Chiatti C, Nilsson MH, Malmgren Fange A. A research-based strategy for managing housing adaptations: study protocol for a quasi-experimental trial. BMC Health Serv Res. 2014 Nov 29;14:602. doi: 10.1186/s12913-014-0602-5.
PubMed 25432718
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Housing Adaptations and Mobility Devices - Evaluation of a New Practice Strategy
- ClinicalTrials.gov ID
- NCT01960582
- Acronym / sponsor ID
- FORMASEvid / FORMAS 2011-907
- Conditions
- Activities of Daily Living, Cost Effectiveness, Housing
- Keywords
- Housing adaptation, Independence, Costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 11 Jan 2013 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 10 Oct 2013 (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 rationale underlying this project is the fact that HA is a very common compensatory interven¬tion within municipality health care, undertaken to support an independent living in the own home. In addition, MD are frequently prescribed and used among HA clients in order to compensate for declined body functions. In spite of this, knowledge of their effects for the individual and the society is still scarce. In particular, systematic, evidence-based strategies based on clear-cut conceptual definitions and descriptions of procedures are lacking. Such strategies are crucial in order to evaluate the effects of HA and MD. In addition, longterm cost-effectiveness evaluations are crucial for policy implementation.
The overarching aim is to investigate outcomes of HA on aspects of home and health for sub-groups of persons with disabilities.
The specific aims are to:
- Investigate the effects of HA on home and health related outcomes, i.e. usability, fear of falling, activity/participation and health-related quality of life for different subgroups of persons, e.g. MD users and non MD-users
- Investigate the use of a new practice strategy for HA on home and health related outcomes for subgroups of persons with disabilities in terms of differences between municipalities
- Investigate societal level outcomes of HA and MD, i.e. costs and quality adjusted life years
- Gain a deeper understanding of the processes behind changes in outcomes We hypothesise that using a structure strategy for housing adaptation and mobility devices case management in ordinary practice in Swedish municipalities increase activity, participation, the usability of the home, and reduces societal costs.
Detailed description
The ultimate goal of the project is to improve the housing situation of older people and people with disabilities, by determining the long term effects of housing adaptations (HA) for clients and society, and transferring this knowledge into guidelines for practitioners in the housing and building planning sector.
Specific research questions are:
RQ1. What are the long-term effects of HA for clients (individual goals achievement, activity, participation, health-related quality of life, usability, falls, functional capacity and use of mobility devices (MD), mortality, health care and social services consumption, and relocation)? RQ2. What are the long-term effects of HA for society (costs and cost- effectiveness)? RQ3. What are the barriers and facilitators to knowledge transfer in the area of HA? RQ4. How can evidence based knowledge be transferred into practical guidelines for housing and building planning in Sweden?
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Practice Strategy | Experimental | Behavioral: New Practice StrategyStructured strategy for assessment and evaluation before and after intervention |
| Ordinary practice | No intervention | –Ordinary practice, not structured |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persons receiving housing adaptation
- Above 20 years
Key exclusion criteria (1 listed)
- Persons with language deficits and/or cognitive decline
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 |
|---|---|---|
| New Practice StrategyApplication of a structured case management strategy on housing adaptation cases | Behavioural | New Practice Strategy |
Primary outcome
ADL Staircase
Time frame: Differences in changes between intervention and control sites at baseline and 3, 6,12, 24 and 36 months after
The ADL Staircase measures dependence on other persons in daily activities. Combined interview and observation
1 secondary outcome
Falls Efficacy Scale- FES-I
Time frame: Differences in changes between intervention and control sites at baseline and 3, 6, 12, 24 and 36 months after
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 9 Oct 2020.
- Derived from this study: PubMed 31684916Malmgren Fange A, Carlsson G, Axmon A, Thordardottir B, Chiatti C, Nilsson MH, Ekstam L. Effects of applying a standardized assessment and evaluation protocol in housing adaptation implementation - results from a quasi-experimental study. BMC Public Health. 2019 Nov 4;19(1):1446. doi: 10.1186/s12889-019-7815-9.
- Derived from this study: PubMed 25432718Ekstam L, Carlsson G, Chiatti C, Nilsson MH, Malmgren Fange A. A research-based strategy for managing housing adaptations: study protocol for a quasi-experimental trial. BMC Health Serv Res. 2014 Nov 29;14:602. doi: 10.1186/s12913-014-0602-5.
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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.
Agneta M Fänge, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Practice Strategy in people with Activities of Daily Living and Cost Effectiveness, run by Lund University at 1 site in Sweden.
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 1 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 9 Oct 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 Sweden. 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?
ADL Staircase (time frame: Differences in changes between intervention and control sites at baseline and 3, 6,12, 24 and 36 months after). 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 NCT01960582, 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 9 Oct 2020; AzTrials last refreshed its copy on 26 Oct 2026.