NCT03168204

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
869

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

May 17, 2017

Last Update Submit

April 24, 2019

Conditions

Older Adults

Outcome Measures

Primary Outcomes (6)

  • 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.

    Assessed during baseline testing + 6 months after inclusion

  • 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)

    Assessed during baseline testing + 6 months after inclusion

  • 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.

    Assessed during baseline testing + 6 months after inclusion

  • 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.

    Assessed during baseline testing + 6 months after inclusion

  • 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.

    Assessed during baseline testing + 6 months after inclusion

  • 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

    Assessed during baseline testing + 6 months after inclusion

Secondary Outcomes (11)

  • Multidimensional frailty

    Assessed during baseline testing + 6 months after inclusion

  • Physical phenotype of frailty

    Assessed during baseline testing + 6 months after inclusion

  • Feeling frail

    Assessed during baseline testing + 6 months after inclusion

  • Resilience

    Assessed during baseline testing + 6 months after inclusion

  • Coping

    Assessed during baseline testing + 6 months after inclusion

  • +6 more secondary outcomes

Study Arms (4)

Risk of being frail experimental group

EXPERIMENTAL
Behavioral: Tailored care and support

Risk of being frail control group

NO INTERVENTION

No/low risk of being frail

NO INTERVENTION

Risk of being frail care avoiders

NO INTERVENTION

Interventions

Tailored care and supportBEHAVIORAL

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).

Risk of being frail experimental group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • men, older than 70 years, living together/widowed/divorced/never married, moved last 10 years
  • women, older than 70 years, widowed/divorced/never married, moved last 10 years

You may not qualify if:

  • Current institutionalization
  • Current hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

OCMW Gent

Ghent, 9000, Belgium

Location

OCMW Knokke-Heist

Knokke-Heist, 8300, Belgium

Location

OCMW Tienen

Tienen, 3300, Belgium

Location

Related Publications (3)

  • 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.

    PMID: 36691193DERIVED

  • 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.

    PMID: 36517745DERIVED

  • 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.

    PMID: 30149798DERIVED

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Liesbeth De Donder, Prof. Dr.

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Liesbeth De Donder

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 30, 2017

Study Start

June 1, 2017

Primary Completion

April 30, 2018

Study Completion

June 30, 2018

Last Updated

April 25, 2019

Record last verified: 2019-04

Locations

BE(3)