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Overall FunctioningCareWellNCT01499797

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

A study testing The CareWell programme in people with Overall Functioning and Incremental Cost-effectiveness Ratio, run by Radboud University Medical Center at 10 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
The CareWell programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
536 participants
Where
10 sitesNetherlands
Study dates
Jan 2011to Mar 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Frail community dwelling elderly patients aged 70 years or above. Frailty is determined with a two-phase screening instrument.

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Netherlands10 sites

  • Huisartsengroep Milbergen (van der Ligt/ Krijgsman), Oude Gracht 16

    Beek-Ubbergen, 6573 BR

  • Gezondheidscentrum de Kroonsteen, Schoolstraat 8

    Malden, 6581 BG

  • Gezondheidscentrum de Vuursteen, Prinsenweg 6

    Molenhoek, 6584 AZ

  • Medisch Centrum Brakkenstein, Kanunnik Boenenstraat 8

    Nijmegen, 6525WJ

  • Gezondheidscentrum Hazenkamp, Vossenlaan 76

    Nijmegen, 6531 SN

  • Huisartsenpraktijk Jacobslaan (Dreijerink/ van der Laan-Evers), Jacobslaan 345

    Nijmegen, 6533 VD

  • Huisartsenpraktijk de Haterse HOED, Couwenbergstraat 34-36

    Nijmegen, 6535RZ

  • Huisartsenpraktijk Danielsplein, Danielsplein 4

    Nijmegen, 6543 NA

  • Medipark (Graat), Hyacinthstraat 3a

    Uden, 5402 ZG

  • Huisartsenpraktijk Ubachs/Vogels, Huissteden 1450

    Wijchen, 6605 HL

Other trials in Netherlands

About this study

Official title: 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.

Being tested
The CareWell programme
Keywords
frailty, frail elders, multicomponent intervention, overall functioning, cost-effectiveness, integrated care, primary care, community dwelling
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The CareWell programmeOther

    Also called Multi-component intervention for frail elderly, Integrated care for community-dwelling frail elderly

    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
Study groups in NCT01499797
Study groupRoleWhat they receive
regular medical careNo interventionIdentified community dwelling frail elderly people receiving regular medical care in their primary care setting
The CareWell programmeExperimentalIdentified community dwelling frail elderly people receiving care in line with the CareWell programme
Receives: Other: The CareWell programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall functioning

    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

    Measured: 18 months

  2. Incremental cost-effectiveness ratio (ICER)

    Measured: 18 months

Secondary outcomes (7)

  1. Perceived quality of life

    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

    Measured: 18 months

  2. Psychological well-being

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

    Measured: 18 months

  3. Social functioning

    Social functioning is measured with the RAND-36 questionnaire.

    Measured: 18 months

  4. Perceived health

    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).

    Measured: 18 months

  5. Utility

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

    Measured: 18 months

  6. Health care consumption

    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.

    Measured: 18 months

  7. Use of welfare services

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
536 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01499797
Sponsor's protocol ID
2010/403
Acronym
CareWell
Status last verified
Oct 2011
First submitted
20 Oct 2011
Last updated
7 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

  • Ruikes FGH, Adang EM, Assendelft WJJ, Schers HJ, Koopmans RTCM, Zuidema SU. Cost-effectiveness of a multicomponent primary care program targeting frail elderly people. BMC Fam Pract. 2018 May 16;19(1):62. doi: 10.1186/s12875-018-0735-4.

    PubMed 29769026

  • Ruikes FG, Meys AR, van de Wetering G, Akkermans RP, van Gaal BG, Zuidema SU, Schers HJ, van Achterberg T, Koopmans RT. The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly. BMC Fam Pract. 2012 Dec 5;13:115. doi: 10.1186/1471-2296-13-115.

    PubMed 23216685

Questions about this trial

What is this clinical trial studying?

A study testing The CareWell programme in people with Overall Functioning and Incremental Cost-effectiveness Ratio, run by Radboud University Medical Center at 10 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall functioning (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01499797, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.

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