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

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.

Study Overview

• Status: Completed
• Conditions: Older Adults
• Intervention / Treatment: Behavioral: Tailored care and support

• Study Type: Interventional
• Enrollment (Actual): 869
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risk of being frail experimental group	Behavioral: 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).
No Intervention: Risk of being frail control group
No Intervention: No/low risk of being frail
No Intervention: Risk of being frail care avoiders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multidimensional frailty	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	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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Collaborators: KU Leuven; Agentschap voor Innovatie door Wetenschap en Technologie; Maastricht University; Universiteit Antwerpen; Hogeschool Gent
• Investigators: Principal Investigator: Liesbeth De Donder, Prof. Dr., Vrije Universiteit Brussel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: D-SCOPE IWT 140027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No