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Completed

NCT Number: NCT01499797

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

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.

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Key information

Conditions

Overall Functioning Frailty Incremental Cost-effectiveness Ratio Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huisartsengroep Milbergen (van der Ligt/ Krijgsman), Oude Gracht 16, Beek-Ubbergen, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The CareWell programme

Other

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

Primary outcomes

  1. 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

  2. Incremental cost-effectiveness ratio (ICER)

    Time frame: 18 months

Secondary outcomes

  1. 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

  2. Psychological well-being

    Time frame: 18 months

    Psychological well-being is measured with the RAND-36 questionnaire.

  3. Social functioning

    Time frame: 18 months

    Social functioning is measured with the RAND-36 questionnaire.

  4. 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).

  5. Utility

    Time frame: 18 months

    Utility is measured with the EQ-5D questionnaire. EQ-5D is embedded in the minimal data set (MDS).

  6. 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.

  7. Use of welfare services

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CareWell

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 26, 2011
Registry last updated
Jun 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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