The CareWell-programme for Community-dwelling Frail Elderly Persons.

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of the CareWell-programme on overall functioning of community-dwelling frail elderly persons. Furthermore, the total costs and the cost-effectiveness of the CareWell-programme, in comparison with regular medical care, will be studied.

Official Title
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Towards a CARE AND WELFARE STANDARD for Community-dwelling Frail Elderly People With Complex Health Problems

Conditions
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Overall Functioning, Incremental Cost-effectiveness Ratio

Intervention / Treatment
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* Other: The CareWell programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Frail community dwelling elderly patients aged 70 years or above. Frailty is determined with a two-phase screening instrument. Exclusion Criteria: Non-frail elders Patients in palliative or end-of-life stages of disease Patients residing in long-term care facilities (care homes and nursing homes) Patients already enrolled in specific dementia-related case-management programmes who lack other health-related problems Patients not speaking or understanding the Dutch language

Ages Eligible for Study
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Minimum Age: 70 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: regular medical care<br>Identified community dwelling frail elderly people receiving regular medical care in their primary care setting | |
| Experimental: The CareWell programme<br>Identified community dwelling frail elderly people receiving care in line with the CareWell programme | Other: The CareWell programme<br>* The CareWell programme contains the following components: multidisciplinary primary care teams working with proactive care plans integrating cure, care and welfare advanced care planning (e.g. recording limitations of treatment, non-resuscitation decisions) medication review case-management guidelines for consultation of in-hospital geriatric experts guidelines for transfers from primary care to home-based facilities and hospital and back practice guidelines for management of common geriatric conditions<br>* Other names: Integrated care for community-dwelling frail elderly;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall functioning | Overall functioning is measured with the Katz-15 questionnaire. Katz-15 is embedded in the minimal data set (MDS). This MDS is used by all research projects of the Dutch National Program on Elderly Care | 18 months | 
| Incremental cost-effectiveness ratio (ICER) |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived quality of life | Perceived quality of life is measured with the RAND-36 questionnaire. RAND-36 is embedded in the minimal data set (MDS). This MDS is used by all research projects of the Dutch National Program on Elderly Care | 18 months | 
| Psychological well-being | Psychological well-being is measured with the RAND-36 questionnaire. | 18 months | 
| Social functioning | Social functioning is measured with the RAND-36 questionnaire. | 18 months | 
| Perceived health | Perceived health is measured with the RAND-36 questionnaire abd Cantril's Self Anchoring Ladder. Both RAND-36 as Cantril's Self Anchoring Ladder are embedded in the minimal data set (MDS). | 18 months | 
| Utility | Utility is measured with the EQ-5D questionnaire. EQ-5D is embedded in the minimal data set (MDS). | 18 months | 
| Health care consumption | Health care consumption including hospital resource consumption, unplanned GP care (evenings, nights and weekends), home care, temporary or permanent admission to a residential care home, temporary or permanent admission to a nursing home, day care, visits to outpatients'clinics. | 18 months | 
| Use of welfare services |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frailty, frail elders, multicomponent intervention, overall functioning, cost-effectiveness, integrated care, primary care, community dwelling