- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07686172
Interprofessional Health Needs Assessment (IHNA) for Older Adults Living at Home (Impact-INHA)
Implementing and Evaluating the Impact of Interprofessional Health Needs Assessment (INHA) for Older Adults Living at Home
This randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of the Interprofessional Health Needs Assessment (IHNA) in older adults living at home. Specifically, the trial will assess the effects of IHNA on health-related quality of life, social care-related quality of life, survival, and health service utilization.
The primary objective is to determine the effect of IHNA on participants' health-related quality of life at 12 months. Secondary objectives are to assess its effects on social care-related quality of life, survival (time to death), health service utilization, and quality-adjusted life years (QALYs) at 6 and 12 months.
연구 개요
상세 설명
Early identification of health needs among home-dwelling elderly adults is crucial for maintaining health and function, improving quality of life, and preventing hospitalizations. When allocating municipal health and care services, healthcare professionals assess functional abilities and health needs. Based on this assessment, services such as emergency alarms, everyday rehabilitation, home nursing care, practical assistance at home, and assistive devices are assigned. However, there is no standardized approach to what should be included in these assessments or how they should be conducted.
This project develops a procedure for interprofessional health needs assessment (IHNA) to systematically identify and address the health needs of older adults living at home. IHNA integrates the older adult's values and preferences into the assessment, ensuring that interventions and services align with their priorities. IHNA incorporates screening tools to provide a structured, holistic assessment of health and social domains.
The project involves co-creation of IHNA with healthcare professionals and older adults, workplace training in the effective use of IHNA, and implementation in two Norwegian municipalities through a randomized controlled trial.
By developing interprofessional practices for assessing health needs and equipping healthcare professionals with screening tools and training, the project will help municipalities provide fairer, more effective services to home-dwelling older adults.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Arnt Egil Ydstebø
연구 장소
-
-
-
Sandnes, 노르웨이, 4306
- 모병
- Sandnes Municipality
-
연락하다:
- Martine Kajander, PhD
- 전화번호: +4747859070
- 이메일: martine.marie.kajander@sandnes.kommune.no
-
Stavanger, 노르웨이, 4014
- 모병
- Stavanger Muncipality
-
연락하다:
- Arnt Egil Ydstebø, PhD
- 전화번호: +47 996 25 223
- 이메일: arnt.egil.ydstebo@stavanger.kommune.no
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 65 years and older
- applying for a municipal health and care service at home (i.e., practical assistance, home nursing, assistive devices, rehabilitation, day care center)
- the health care service will have a duration of more than 2 weeks
Exclusion Criteria:
- younger than 65 years
- diagnosed with dementia
- life expectancy shorter than 6 months
- applying for a nursing home placement
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: INHA Intervention group
The intervention group will be assessed using INHA
|
Interprofessional teams with a nurse, physiotherapist, or occupational therapist from Stavanger and Sandnes municipalities will assess participants in the intervention group using the Interprofessional Health Needs Assessment (INHA) procedure. INHA includes screening tools to assess mobility, cognition, mental health, nutrition and oral health, vision and hearing, activities of daily living, social network, physical and behavioral health. Based on the IHNA findings, the interprofessional teams, in collaboration with the older adult, will decide on the allocation of municipal health services, make referrals, and provide advice on available preventive and health promotion interventions from the municipality's health and care services and relevant voluntary and private actors. |
|
간섭 없음: Control group
The participants in the control group will be assessed by the standard assessment form used by the municipality and have services allocated as usual.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Health-related quality of life
기간: Baseline, 6 months and 12 months
|
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to perform.
Responses are combined into a 5-digit health-state profile, with 11111 representing the best health state and 55555 the worst health state.
Health state will be converted into a utility index score, with higher scores indicating better health-related quality of life.
The primary outcome will be the change in EQ-5D-5L utility index score from baseline to 12 months.
|
Baseline, 6 months and 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-rated health
기간: Baseline, 6 months, and 12 months
|
The EuroQol Visual Analog Scale (EQ VAS) will be assessed as a secondary outcome measure of self-rated health. Participants rate their current health on a scale from 0 to 100. A score of 100 is equivalent to the best possible health. A score of 0 is equivalent to the worst possible health. Changes in EQ VAS scores from baseline to 6 months and 12 months will be evaluated, with higher scores indicating better perceived health. |
Baseline, 6 months, and 12 months
|
|
Social care related quality of life
기간: Baseline, 6 months, and 12 months
|
The Adult Social Care Outcomes Toolkit (ASCOT) will be used as a secondary outcome measure of social care-related quality of life.
ASCOT covers eight domains: control over daily life, personal cleanliness and comfort, food and drink, personal safety, social participation and involvement, occupation, accommodation cleanliness and comfort, and dignity.
Each domain has four response options scored from 0 to 3, with higher scores indicating better outcomes.
Domain responses will be combined into an overall ASCOT score, with higher scores indicating better social care-related quality of life.
Changes in ASCOT scores from baseline to 6 months and 12 months will be evaluated.
|
Baseline, 6 months, and 12 months
|
|
Time to death (survival)
기간: Baseline to 12 months
|
Time from baseline to death within 12 months will be obtained from municipal electronic patient records.
Longer survival indicates a better outcome.
|
Baseline to 12 months
|
|
Health care utilization
기간: 6 and 12 months
|
Health care utilization will be assessed as a secondary outcome measure.
Data on nursing home admissions, municipal emergency service visits, and hospital admissions will be obtained from the Norwegian Registry for Primary Health Care and the Norwegian Patient Registry.
Health care utilization will be measured as the number of nursing home admissions, municipal emergency service visits, and hospital admissions during the 6- and 12-month follow-up periods.
Lower health care utilization indicates better outcomes.
|
6 and 12 months
|
|
Quality-Adjusted Life Years ( QALYs)
기간: Baseline, 6 months and 12 months
|
Quality-Adjusted Life Years (QALYs) will be a secondary outcome, measuring the combined effects of the intervention on survival and health-related quality of life.
QALYs will be calculated over the 12-month follow-up period by combining survival with health utility values derived from the EQ-5D.
Higher QALYs indicate better overall health outcomes.
QALY estimates will be used to inform cost-effectiveness analyses.
|
Baseline, 6 months and 12 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 355225 (기타 보조금/기금 번호: The Research Council Of Norway)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .