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Older AdultsD-SCOPENCT03168204

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

A study testing Tailored care and support in people with Older Adults, run by Vrije Universiteit Brussel at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Older Adults
What is being tested?
Tailored care and support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
869 participants
Where
3 sitesBelgium
Study dates
1 Jun 2017to 30 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • Current institutionalization
  • Current hospitalization

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • OCMW Gent

    Ghent, 9000

  • OCMW Knokke-Heist

    Knokke-Heist, 8300

  • OCMW Tienen

    Tienen, 3300

Other trials in Belgium

About this study

Official 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

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.

Conditions
Older Adults
Being tested
Tailored care and support

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tailored care and supportBehavioural

    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).

Study groups in NCT03168204
Study groupRoleWhat they receive
Risk of being frail experimental groupExperimentalNot described
Receives: Behavioral: Tailored care and support
Risk of being frail control groupNo interventionNot described
No/low risk of being frailNo interventionNot described
Risk of being frail care avoidersNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Quality of Life at 6 months

    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.

    Measured: Assessed during baseline testing + 6 months after inclusion

  2. Change from baseline Satisfaction with Life at 6 months

    The Satisfaction with Life Scale will be administered to explore the life satisfaction of the participants (5 items)

    Measured: Assessed during baseline testing + 6 months after inclusion

  3. Change from baseline sense of mastery at 6 months

    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.

    Measured: Assessed during baseline testing + 6 months after inclusion

  4. Change from baseline Meaning in Life at 6 months

    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.

    Measured: Assessed during baseline testing + 6 months after inclusion

  5. Change from baseline Community Inclusion at 6 months

    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.

    Measured: Assessed during baseline testing + 6 months after inclusion

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

    One self-constructed question (1 item) will assess if the older person lives at home in a qualitative manner

    Measured: Assessed during baseline testing + 6 months after inclusion

Secondary outcomes (11)

  1. Multidimensional frailty

    The Comprehensive Frailty Assessment Instrument (CFAI) will be used to measure multidimensional frailty: physical, cognitive, psychological, social and environmental frailty

    Measured: Assessed during baseline testing + 6 months after inclusion

  2. Physical phenotype of frailty

    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

    Measured: Assessed during baseline testing + 6 months after inclusion

  3. Feeling frail

    The subjective feeling of frailty will be assessed using 1 self-constructed question and will assess to what extent an older person feels frail

    Measured: Assessed during baseline testing + 6 months after inclusion

  4. Resilience

    Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC2), which is an abbreviated 2-item version of the original scale

    Measured: Assessed during baseline testing + 6 months after inclusion

  5. Coping

    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

    Measured: Assessed during baseline testing + 6 months after inclusion

  6. Help needed for activities in daily life

    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)

    Measured: Assessed during baseline testing + 6 months after inclusion

  7. Informal and formal care

    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.

    Measured: Assessed during baseline testing + 6 months after inclusion

  8. Medical care

    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.

    Measured: Assessed during baseline testing + 6 months after inclusion

  9. Leisure time

    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

    Measured: Assessed during baseline testing + 6 months after inclusion

  10. Neighborhood

    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.

    Measured: Assessed during baseline testing + 6 months after inclusion

  11. Life-events

    A shortened version of the Geriatric Adverse Life Events Scale (GALES) will be adapted to assess to occurrence of life-events (11 items)

    Measured: Assessed during baseline testing + 6 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start1 Jun 2017
  3. Primary completion30 Apr 2018
  4. Study completion30 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
869 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03168204
Sponsor's protocol ID
D-SCOPE IWT 140027
Acronym
D-SCOPE
Status last verified
Apr 2019
First submitted
17 May 2017
Last updated
25 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Van der Elst M, Schoenmakers B, Dierckx E, De Donder L, De Roeck E, Duppen D, Fret B, Schols JMGA, Kempen GIJM, De Lepeleire J. A search for relevant contextual factors in intervention studies: a stepwise approach with online information. BMJ Open. 2022 Sep 9;12(9):e057048. doi: 10.1136/bmjopen-2021-057048.

    PubMed 36691193

  • Dierckx E, Duppen D, Hoens S, Switsers L, Smetcoren AS, De Donder L, D-Scope. Effectiveness, satisfaction and meaningfulness of a 6-step detection and prevention program for frail community-dwelling older adults: a mixed-method evaluation. BMC Geriatr. 2022 Dec 14;22(1):966. doi: 10.1186/s12877-022-03504-7.

    PubMed 36517745

  • Lambotte D, De Donder L, De Roeck EE, Hoeyberghs LJ, van der Vorst A, Duppen D, Van der Elst M, Fret B, Dury S, Smetcoren AS, Kardol MJM, Engelborghs S, De Deyn PP, De Witte N, Schols JMGA, Kempen GIJM, Zijlstra GAR, De Lepeleire J, Schoenmakers B, Verte D, Dierckx E. Randomized controlled trial to evaluate a prevention program for frail community-dwelling older adults: a D-SCOPE protocol. BMC Geriatr. 2018 Aug 27;18(1):194. doi: 10.1186/s12877-018-0875-3.

    PubMed 30149798

Questions about this trial

What is this clinical trial studying?

A study testing Tailored care and support in people with Older Adults, run by Vrije Universiteit Brussel at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Quality of Life at 6 months (time frame: Assessed during baseline testing + 6 months after inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03168204, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.

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