- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
The aim of this randomized controlled trial is 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 for a structured and 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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Arnt Egil Ydstebø
Lokalizacje studiów
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Sandnes, Norwegia, 4306
- Rekrutacyjny
- Sandnes Municipality
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Kontakt:
- Martine Kajander, PhD
- Numer telefonu: +4747859070
- E-mail: martine.marie.kajander@sandnes.kommune.no
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Stavanger, Norwegia, 4014
- Rekrutacyjny
- Stavanger Muncipality
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Kontakt:
- Arnt Egil Ydstebø, PhD
- Numer telefonu: +47 996 25 223
- E-mail: arnt.egil.ydstebo@stavanger.kommune.no
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: INHA Intervention group
The intervention group will be assessed using INHA
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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 behavioural health. Based on the IHNA findings, the interprofessional teams, in collaboration with the older adult, will decide on allocating municipal health services, making referrals, and giving advice on available preventive and health promotion interventions from the municipality's health and care services and relevant voluntary and private actors. |
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Brak interwencji: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Health-related quality of life
Ramy czasowe: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Self-rated health
Ramy czasowe: Baseline, 6 months, and 12 months
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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
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Social care related quality of life
Ramy czasowe: Baseline, 6 months, and 12 months
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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.
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Baseline, 6 months, and 12 months
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Time to death (survival)
Ramy czasowe: Baseline to 12 months
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Time from baseline to death within 12 months will be obtained from municipal electronic patient records.
Longer survival indicates a better outcome.
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Baseline to 12 months
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Health care utilization
Ramy czasowe: 6 and 12 months
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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.
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6 and 12 months
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Quality-Adjusted Life Years ( QALYs)
Ramy czasowe: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 355225 (Inny numer grantu/finansowania: The Research Council Of Norway)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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