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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03168204
Acronym
D-SCOPE
Enrollment
869
Registered
2017-05-30
Start date
2017-06-01
Completion date
2018-06-30
Last updated
2019-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older Adults

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.

Interventions

BEHAVIORALTailored 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).

Sponsors

Hogeschool Gent
CollaboratorUNKNOWN
Universiteit Antwerpen
CollaboratorOTHER
KU Leuven
CollaboratorOTHER
Maastricht University
CollaboratorOTHER
Agentschap voor Innovatie door Wetenschap en Technologie
CollaboratorOTHER
Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline Quality of Life at 6 monthsAssessed during baseline testing + 6 months after inclusionOne 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.
Change from baseline Satisfaction with Life at 6 monthsAssessed during baseline testing + 6 months after inclusionThe Satisfaction with Life Scale will be administered to explore the life satisfaction of the participants (5 items)
Change from baseline sense of mastery at 6 monthsAssessed during baseline testing + 6 months after inclusionTo 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.
Change from baseline Meaning in Life at 6 monthsAssessed during baseline testing + 6 months after inclusionMeaning 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.
Change from baseline Community Inclusion at 6 monthsAssessed during baseline testing + 6 months after inclusionCommunity 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.
Change from baseline aging well in place at 6 monthsAssessed during baseline testing + 6 months after inclusionOne self-constructed question (1 item) will assess if the older person lives at home in a qualitative manner

Secondary

MeasureTime frameDescription
Informal and formal careAssessed during baseline testing + 6 months after inclusionOlder 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.
Medical careAssessed during baseline testing + 6 months after inclusionThe 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.
Multidimensional frailtyAssessed during baseline testing + 6 months after inclusionThe Comprehensive Frailty Assessment Instrument (CFAI) will be used to measure multidimensional frailty: physical, cognitive, psychological, social and environmental frailty
NeighborhoodAssessed during baseline testing + 6 months after inclusionDifferent 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.
Life-eventsAssessed during baseline testing + 6 months after inclusionA shortened version of the Geriatric Adverse Life Events Scale (GALES) will be adapted to assess to occurrence of life-events (11 items)
Leisure timeAssessed during baseline testing + 6 months after inclusionLeisure 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
Physical phenotype of frailtyAssessed during baseline testing + 6 months after inclusionThe Fried's phenotype of frailty will be used to assess the physical phenotype of frailty as well as the questionnaire of Op het Veld
Feeling frailAssessed during baseline testing + 6 months after inclusionThe subjective feeling of frailty will be assessed using 1 self-constructed question and will assess to what extent an older person feels frail
ResilienceAssessed during baseline testing + 6 months after inclusionResilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC2), which is an abbreviated 2-item version of the original scale
CopingAssessed during baseline testing + 6 months after inclusionCoping 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
Help needed for activities in daily lifeAssessed during baseline testing + 6 months after inclusionOlder 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)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026