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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Older Adults

Intervention / Treatment
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* Behavioral: Tailored care and support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risk of being frail experimental group<br> | Behavioral: Tailored care and support<br>* 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).<br>|
| No Intervention: Risk of being frail control group<br> | |
| No Intervention: No/low risk of being frail<br> | |
| No Intervention: Risk of being frail care avoiders<br> | |

What is the study measuring?
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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 |