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

24 aprile 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

869

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

60 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Risk of being frail experimental group
Comportamentale: 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).
Nessun intervento: Risk of being frail control group
Nessun intervento: No/low risk of being frail
Nessun intervento: Risk of being frail care avoiders

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline Quality of Life at 6 months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Multidimensional frailty
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Vrije Universiteit Brussel

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2017

Completamento primario (Effettivo)

30 aprile 2018

Completamento dello studio (Effettivo)

30 giugno 2018

Date di iscrizione allo studio

Primo inviato

17 maggio 2017

Primo inviato che soddisfa i criteri di controllo qualità

23 maggio 2017

Primo Inserito (Effettivo)

30 maggio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • D-SCOPE IWT 140027

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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