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Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults (D-SCOPE)

24. April 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

869

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
      • Gent, Belgien, 9000
        • OCMW Gent
      • Knokke-Heist, Belgien, 8300
        • OCMW Knokke-Heist
      • Tienen, Belgien, 3300
        • OCMW Tienen

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

60 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Risk of being frail experimental group
Verhalten: Tailored care and support
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).
Kein Eingriff: Risk of being frail control group
Kein Eingriff: No/low risk of being frail
Kein Eingriff: Risk of being frail care avoiders

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline Quality of Life at 6 months
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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.
Assessed during baseline testing + 6 months after inclusion
Change from baseline Satisfaction with Life at 6 months
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
The Satisfaction with Life Scale will be administered to explore the life satisfaction of the participants (5 items)
Assessed during baseline testing + 6 months after inclusion
Change from baseline sense of mastery at 6 months
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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.
Assessed during baseline testing + 6 months after inclusion
Change from baseline Meaning in Life at 6 months
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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.
Assessed during baseline testing + 6 months after inclusion
Change from baseline Community Inclusion at 6 months
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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.
Assessed during baseline testing + 6 months after inclusion
Change from baseline aging well in place at 6 months
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
One self-constructed question (1 item) will assess if the older person lives at home in a qualitative manner
Assessed during baseline testing + 6 months after inclusion

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Multidimensional frailty
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
The Comprehensive Frailty Assessment Instrument (CFAI) will be used to measure multidimensional frailty: physical, cognitive, psychological, social and environmental frailty
Assessed during baseline testing + 6 months after inclusion
Physical phenotype of frailty
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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
Assessed during baseline testing + 6 months after inclusion
Feeling frail
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
The subjective feeling of frailty will be assessed using 1 self-constructed question and will assess to what extent an older person feels frail
Assessed during baseline testing + 6 months after inclusion
Resilience
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC2), which is an abbreviated 2-item version of the original scale
Assessed during baseline testing + 6 months after inclusion
Coping
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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
Assessed during baseline testing + 6 months after inclusion
Help needed for activities in daily life
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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)
Assessed during baseline testing + 6 months after inclusion
Informal and formal care
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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.
Assessed during baseline testing + 6 months after inclusion
Medical care
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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.
Assessed during baseline testing + 6 months after inclusion
Leisure time
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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
Assessed during baseline testing + 6 months after inclusion
Neighborhood
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
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.
Assessed during baseline testing + 6 months after inclusion
Life-events
Zeitfenster: Assessed during baseline testing + 6 months after inclusion
A shortened version of the Geriatric Adverse Life Events Scale (GALES) will be adapted to assess to occurrence of life-events (11 items)
Assessed during baseline testing + 6 months after inclusion

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Vrije Universiteit Brussel

Mitarbeiter

KU Leuven
Agentschap voor Innovatie door Wetenschap en Technologie
Maastricht University
Universiteit Antwerpen
Hogeschool Gent

Ermittler

  • Hauptermittler: Liesbeth De Donder, Prof. Dr., Vrije Universiteit Brussel

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juni 2017

Primärer Abschluss (Tatsächlich)

30. April 2018

Studienabschluss (Tatsächlich)

30. Juni 2018

Studienanmeldedaten

Zuerst eingereicht

17. Mai 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Mai 2017

Zuerst gepostet (Tatsächlich)

30. Mai 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. April 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. April 2019

Zuletzt verifiziert

1. April 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • D-SCOPE IWT 140027

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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