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

24 de abril de 2019 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

869

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

60 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Risk of being frail experimental group
Comportamental: 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).
Sem intervenção: Risk of being frail control group
Sem intervenção: No/low risk of being frail
Sem intervenção: Risk of being frail care avoiders

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline Quality of Life at 6 months
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Multidimensional frailty
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Vrije Universiteit Brussel

Colaboradores

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

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2017

Conclusão Primária (Real)

30 de abril de 2018

Conclusão do estudo (Real)

30 de junho de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

17 de maio de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de maio de 2017

Primeira postagem (Real)

30 de maio de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de abril de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de abril de 2019

Última verificação

1 de abril de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • D-SCOPE IWT 140027

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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