Clinical trial NCT03168204: Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Hogeschool Gent
name: Universiteit Antwerpen
name: KU Leuven
name: Maastricht University
name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2017-05-30
Enrollment: 869
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Quality of Life at 6 months
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Change from baseline Satisfaction with Life at 6 months
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Change from baseline sense of mastery at 6 months
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Change from baseline Meaning in Life at 6 months
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Change from baseline Community Inclusion at 6 months
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Change from baseline aging well in place at 6 months
timeFrame: Assessed during baseline testing + 6 months after inclusion
Secondary outcomes:
measure: Multidimensional frailty
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Physical phenotype of frailty
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Feeling frail
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Resilience
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Coping
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Help needed for activities in daily life
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Informal and formal care
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Medical care
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Leisure time
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Neighborhood
timeFrame: Assessed during baseline testing + 6 months after inclusion
measure: Life-events
timeFrame: Assessed during baseline testing + 6 months after inclusion
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: OCMW Gent
city: Knokke-Heist
country: Belgium
facility: OCMW Knokke-Heist
city: Tienen
country: Belgium
facility: OCMW Tienen
Study officials:
affiliation: Vrije Universiteit Brussel
name: Liesbeth De Donder, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.