- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01960582
Evaluation of Housing Adaptations and Mobility Devices (FORMASEvid)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lund, Sweden, 221 00
- Department of Health Sciences, Lund University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Persons receiving housing adaptation
- Above 20 years
Exclusion Criteria:
- Persons with language deficits and/or cognitive decline
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: New Practice Strategy
Structured strategy for assessment and evaluation before and after intervention
|
Application of a structured case management strategy on housing adaptation cases
|
No Intervention: Ordinary practice
Ordinary practice, not structured
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Differences in changes between intervention and control sites at baseline and 3, 6,12, 24 and 36 months after
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
FES-I measures perceived fear of falling
|
Differences in changes between intervention and control sites at baseline and 3, 6, 12, 24 and 36 months after
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability of the home, UIMH
Time Frame: Differences in changes between intervention and control sites between baseline and 3, 6,12,24 and 36 months after
|
Self-rated assessment measuring the extent to which the person can perform Daily activities in the housing
|
Differences in changes between intervention and control sites between baseline and 3, 6,12,24 and 36 months after
|
Costs of housing adaptations
Time Frame: 3,6, 12, 24 and 36 months after, for the whole sample
|
The actual costs for the housing adaptation, including costs for travel, work hours, and material will be calculated based on invoices benefit
|
3,6, 12, 24 and 36 months after, for the whole sample
|
Cost-benefit for client and society
Time Frame: At 24 and 36 months after the housing adaptation, for the whole sample
|
The cost-benefit of the housing adaptation will be calculated based on health economic models utilising data from EQ-5D instrument
|
At 24 and 36 months after the housing adaptation, for the whole sample
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Agneta M Fänge, PhD, Lund University
Publications and helpful links
General 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.
- Ekstam 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FORMAS 2011-907
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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