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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
536

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Healthcare Authority
Health insurances CZ
Health insurances UVIT
City of Nijmegen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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