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

June 6, 2013 updated by: Radboud University Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

536

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Beek-Ubbergen, Netherlands, 6573 BR
        • Huisartsengroep Milbergen (van der Ligt/ Krijgsman), Oude Gracht 16
      • Malden, Netherlands, 6581 BG
        • Gezondheidscentrum de Kroonsteen, Schoolstraat 8
      • Molenhoek, Netherlands, 6584 AZ
        • Gezondheidscentrum de Vuursteen, Prinsenweg 6
      • Nijmegen, Netherlands, 6525WJ
        • Medisch Centrum Brakkenstein, Kanunnik Boenenstraat 8
      • Nijmegen, Netherlands, 6531 SN
        • Gezondheidscentrum Hazenkamp, Vossenlaan 76
      • Nijmegen, Netherlands, 6533 VD
        • Huisartsenpraktijk Jacobslaan (Dreijerink/ van der Laan-Evers), Jacobslaan 345
      • Nijmegen, Netherlands, 6535RZ
        • Huisartsenpraktijk de Haterse HOED, Couwenbergstraat 34-36
      • Nijmegen, Netherlands, 6543 NA
        • Huisartsenpraktijk Danielsplein, Danielsplein 4
      • Uden, Netherlands, 5402 ZG
        • Medipark (Graat), Hyacinthstraat 3a
      • Wijchen, Netherlands, 6605 HL
        • Huisartsenpraktijk Ubachs/Vogels, Huissteden 1450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: regular medical care
Identified community dwelling frail elderly people receiving regular medical care in their primary care setting
Experimental: The CareWell programme
Identified community dwelling frail elderly people receiving care in line with the CareWell programme
Other: The CareWell programme

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
Other Names:
  • Multi-component intervention for frail elderly
  • Integrated care for community-dwelling frail elderly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months
Incremental cost-effectiveness ratio (ICER)
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived quality of life
Time Frame: 18 months
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
Time Frame: 18 months
Psychological well-being is measured with the RAND-36 questionnaire.
18 months
Social functioning
Time Frame: 18 months
Social functioning is measured with the RAND-36 questionnaire.
18 months
Perceived health
Time Frame: 18 months
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
Time Frame: 18 months
Utility is measured with the EQ-5D questionnaire. EQ-5D is embedded in the minimal data set (MDS).
18 months
Health care consumption
Time Frame: 18 months
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
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Healthcare Authority
Health insurances CZ
Health insurances UVIT
City of Nijmegen

Investigators

  • Principal Investigator: Raymond Koopmans, Professor, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

June 7, 2013

Last Update Submitted That Met QC Criteria

June 6, 2013

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010/403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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