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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 de Haterse HOED, Couwenbergstraat 34-36
Nijmegen, Netherlands, 6535RZ
Huisartsenpraktijk Danielsplein, Danielsplein 4
Nijmegen, Netherlands, 6543 NA
Medisch Centrum Brakkenstein, Kanunnik Boenenstraat 8
Nijmegen, Netherlands, 6525WJ
Gezondheidscentrum Hazenkamp, Vossenlaan 76
Nijmegen, Netherlands, 6531 SN
Huisartsenpraktijk Jacobslaan (Dreijerink/ van der Laan-Evers), Jacobslaan 345
Nijmegen, Netherlands, 6533 VD
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 September 29, 2014