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Completed

NCT Number: NCT03168204

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OCMW Gent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored care and support

Behavioral

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).

Primary outcomes

  1. Change from baseline Quality of Life at 6 months

    Time frame: 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.

  2. Change from baseline Satisfaction with Life at 6 months

    Time frame: 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)

  3. Change from baseline sense of mastery at 6 months

    Time frame: 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.

  4. Change from baseline Meaning in Life at 6 months

    Time frame: 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.

  5. Change from baseline Community Inclusion at 6 months

    Time frame: 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.

  6. Change from baseline aging well in place at 6 months

    Time frame: 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

Secondary outcomes

  1. Multidimensional frailty

    Time frame: 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

  2. Physical phenotype of frailty

    Time frame: 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

  3. Feeling frail

    Time frame: 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

  4. Resilience

    Time frame: 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

  5. Coping

    Time frame: 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

  6. Help needed for activities in daily life

    Time frame: 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)

  7. Informal and formal care

    Time frame: 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.

  8. Medical care

    Time frame: 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.

  9. Leisure time

    Time frame: 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

  10. Neighborhood

    Time frame: 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.

  11. Life-events

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

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

Registry information

Official study title

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

Acronym: D-SCOPE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 30, 2017
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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