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Clinical Trials/NCT01499797
NCT01499797CompletedNot Applicable

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

Radboud University Medical Center20 sites in 1 country536 target enrollmentStarted: January 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
536
Locations
20
Primary Endpoint
Overall functioning

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
70 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Overall functioning

Time Frame: 18 months

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

Incremental cost-effectiveness ratio (ICER)

Time Frame: 18 months

Secondary Outcomes

  • Perceived quality of life(18 months)
  • Psychological well-being(18 months)
  • Social functioning(18 months)
  • Perceived health(18 months)
  • Utility(18 months)
  • Health care consumption(18 months)
  • Use of welfare services(18 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (20)

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