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- Klinische proef NCT03168204
Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults (D-SCOPE)
24 april 2019 bijgewerkt door: Liesbeth De Donder, Vrije Universiteit Brussel
Study Protocol of the D-SCOPE Project With a Randomized Controlled Trial, Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults
The evaluation of a detection and prevention program which aims to create a continuum of care and support for frail community-dwelling older people (from early detection, over intervention, to follow-up).
First, the program aims to develop methods to easily, accurately and timely detect and prevent a negative frailty-balance in older people.
Second, the study aims to improve the quality and efficacy of care and support given to frail community-dwelling older people.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
869
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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-
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Gent, België, 9000
- OCMW Gent
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Knokke-Heist, België, 8300
- OCMW Knokke-Heist
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Tienen, België, 3300
- OCMW Tienen
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
60 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
Sample 1: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: at least one selection criterion)
- Gender: 75 men - 75 women
- Age: 25 older people aged between 60 and 70 years old - 125 older people older than 70 years
- Marital status: 50 older people with partner - 100 older people without partner
- Living situation: 100 older people who have not moved last 10 years - 50 older people who have moved last 10 years
- Migration background: 100 older people born in Belgium - 50 older people born elsewhere
Sample 2: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: all selection criteria at once)
- 75 men, older than 70 years, living together/widowed/divorced/never married, moved last 10 years
- 75 women, older than 70 years, widowed/divorced/never married, moved last 10 years
Exclusion Criteria:
- Current institutionalization
- Current hospitalization
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Risk of being frail experimental group
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Offering tailored care and support whereby the competences, strengths and resources of the older person are taken into account.The intervention will be an enhancement of usual care and will depend on the availability of the municipality, and could be formal (i.e., home care) or informal (e.g.
activities of an older adult's association).
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Geen tussenkomst: Risk of being frail control group
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Geen tussenkomst: No/low risk of being frail
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Geen tussenkomst: Risk of being frail care avoiders
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change from baseline Quality of Life at 6 months
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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One question from the WHOQOL-BREF will be used to measure the quality of life of participants (1 item).
Older participants will also be asked to rate their quality of life on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Satisfaction with Life at 6 months
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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The Satisfaction with Life Scale will be administered to explore the life satisfaction of the participants (5 items)
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline sense of mastery at 6 months
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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To assess the sense of mastery of older people, the current mastery questionnaire will be used and one self-constructed item will be added which will assess mastery in relation to others.
Older participants will also be asked to rate their mastery on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Meaning in Life at 6 months
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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Meaning in life will be evaluated with 5 items from the Meaning in Life Questionnaire (MLQ).
Older participants will also be asked to rate their meaning in life on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Community Inclusion at 6 months
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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Community inclusion will be measured using 1 item from the Community Integration Measure (CIM).
Older participants will also be asked to rate their community inclusion on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline aging well in place at 6 months
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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One self-constructed question (1 item) will assess if the older person lives at home in a qualitative manner
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Assessed during baseline testing + 6 months after inclusion
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Multidimensional frailty
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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The Comprehensive Frailty Assessment Instrument (CFAI) will be used to measure multidimensional frailty: physical, cognitive, psychological, social and environmental frailty
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Assessed during baseline testing + 6 months after inclusion
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Physical phenotype of frailty
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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The Fried's phenotype of frailty will be used to assess the physical phenotype of frailty as well as the questionnaire of Op het Veld
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Assessed during baseline testing + 6 months after inclusion
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Feeling frail
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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The subjective feeling of frailty will be assessed using 1 self-constructed question and will assess to what extent an older person feels frail
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Assessed during baseline testing + 6 months after inclusion
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Resilience
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC2), which is an abbreviated 2-item version of the original scale
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Assessed during baseline testing + 6 months after inclusion
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Coping
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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Coping will be measured using 12 items from the BRIEF cope.
Two items from active coping, positive reframing, religion, use of emotional support and self-distraction and one item from acceptance and behavioral disengagement will be used
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Assessed during baseline testing + 6 months after inclusion
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Help needed for activities in daily life
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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Older people will be asked if they need help with 8 activities of daily life, and to what extent the help they receive for these activities is sufficient.
These questions are adapted from the questionnaire of the Belgian Ageing Studies (BAS)
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Assessed during baseline testing + 6 months after inclusion
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Informal and formal care
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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Older people will be asked if they receive care from 6 informal and 14 formal caregivers and if they are satisfied with the help they receive from these caregivers.
These questions are adapted from the BAS-questionnaire.
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Assessed during baseline testing + 6 months after inclusion
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Medical care
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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The participants will be asked if they needed to go to the hospital, to a residential setting and a rehabilitation center over the past 6 months (day case/overnight stay).
These questions are adapted from the Health Interview Survey.
In addition, the participants will be asked when they visited the general practitioner for the last time over the last 6 months.
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Assessed during baseline testing + 6 months after inclusion
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Leisure time
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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Leisure time will be measured by using an adapted question with 8 items derived from the BAS-questionnaire and will examine how often the participants perform the listed activities
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Assessed during baseline testing + 6 months after inclusion
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Neighborhood
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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Different dimensions of neighborhood will be assessed.
First, the social environment will be administered by using 3 items from the social cohesion dimension of the Neighbourhood Scale.
Second, the physical environment will be explored by using 4 items from the BAS-questionnaire as well as from the Neighbourhood Environment Walkability Scale.
Finally, low-key participation will be examined by using 2 items from the questionnaire of Oswald & Konopik.
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Assessed during baseline testing + 6 months after inclusion
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Life-events
Tijdsspanne: Assessed during baseline testing + 6 months after inclusion
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A shortened version of the Geriatric Adverse Life Events Scale (GALES) will be adapted to assess to occurrence of life-events (11 items)
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Assessed during baseline testing + 6 months after inclusion
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Liesbeth De Donder, Prof. Dr., Vrije Universiteit Brussel
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juni 2017
Primaire voltooiing (Werkelijk)
30 april 2018
Studie voltooiing (Werkelijk)
30 juni 2018
Studieregistratiedata
Eerst ingediend
17 mei 2017
Eerst ingediend dat voldeed aan de QC-criteria
23 mei 2017
Eerst geplaatst (Werkelijk)
30 mei 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 april 2019
Laatste update ingediend die voldeed aan QC-criteria
24 april 2019
Laatst geverifieerd
1 april 2019
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- D-SCOPE IWT 140027
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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