- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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?
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Lund, 스웨덴, 221 00
- Department of Health Sciences, Lund University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Persons receiving housing adaptation
- Above 20 years
Exclusion Criteria:
- Persons with language deficits and/or cognitive decline
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: New Practice Strategy
Structured strategy for assessment and evaluation before and after intervention
|
Application of a structured case management strategy on housing adaptation cases
|
|
간섭 없음: Ordinary practice
Ordinary practice, not structured
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ADL Staircase
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Falls Efficacy Scale- FES-I
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Usability of the home, UIMH
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Agneta M Fänge, PhD, Lund University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FORMAS 2011-907
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .