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

This study has been completed.
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Healthcare Authority
Health insurances CZ
Health insurances UVIT
City of Nijmegen
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01499797
First received: October 20, 2011
Last updated: June 6, 2013
Last verified: October 2011
  Purpose

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.


Condition Intervention
Overall Functioning
Incremental Cost-effectiveness Ratio
Other: The CareWell programme

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Towards a CARE AND WELFARE STANDARD for Community-dwelling Frail Elderly People With Complex Health Problems

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Overall functioning [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perceived quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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

  • Psychological well-being [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Psychological well-being is measured with the RAND-36 questionnaire.

  • Social functioning [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Social functioning is measured with the RAND-36 questionnaire.

  • Perceived health [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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).

  • Utility [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Utility is measured with the EQ-5D questionnaire. EQ-5D is embedded in the minimal data set (MDS).

  • Health care consumption [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.

  • Use of welfare services [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 536
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499797

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

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01499797     History of Changes
Other Study ID Numbers: 2010/403
Study First Received: October 20, 2011
Last Updated: June 6, 2013
Health Authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development

Keywords provided by Radboud University:
frailty
frail elders
multicomponent intervention
overall functioning
cost-effectiveness
integrated care
primary care
community dwelling

ClinicalTrials.gov processed this record on April 15, 2014