NCT01499797

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 7, 2013

Status Verified

October 1, 2011

Enrollment Period

2 years

First QC Date

October 20, 2011

Last Update Submit

June 6, 2013

Conditions

Keywords

frailtyfrail eldersmulticomponent interventionoverall functioningcost-effectivenessintegrated careprimary carecommunity dwelling

Outcome Measures

Primary Outcomes (2)

  • 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

    18 months

  • Incremental cost-effectiveness ratio (ICER)

    18 months

Secondary Outcomes (7)

  • Perceived quality of life

    18 months

  • Psychological well-being

    18 months

  • Social functioning

    18 months

  • Perceived health

    18 months

  • Utility

    18 months

  • +2 more secondary outcomes

Study Arms (2)

regular medical care

NO INTERVENTION

Identified community dwelling frail elderly people receiving regular medical care in their primary care setting

The CareWell programme

EXPERIMENTAL

Identified community dwelling frail elderly people receiving care in line with the CareWell programme

Other: The CareWell programme

Interventions

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

Also known as: Multi-component intervention for frail elderly, Integrated care for community-dwelling frail elderly
The CareWell programme

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

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

Beek-Ubbergen, 6573 BR, Netherlands

Location

Gezondheidscentrum de Kroonsteen, Schoolstraat 8

Malden, 6581 BG, Netherlands

Location

Gezondheidscentrum de Vuursteen, Prinsenweg 6

Molenhoek, 6584 AZ, Netherlands

Location

Medisch Centrum Brakkenstein, Kanunnik Boenenstraat 8

Nijmegen, 6525WJ, Netherlands

Location

Gezondheidscentrum Hazenkamp, Vossenlaan 76

Nijmegen, 6531 SN, Netherlands

Location

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

Nijmegen, 6533 VD, Netherlands

Location

Huisartsenpraktijk de Haterse HOED, Couwenbergstraat 34-36

Nijmegen, 6535RZ, Netherlands

Location

Huisartsenpraktijk Danielsplein, Danielsplein 4

Nijmegen, 6543 NA, Netherlands

Location

Medipark (Graat), Hyacinthstraat 3a

Uden, 5402 ZG, Netherlands

Location

Huisartsenpraktijk Ubachs/Vogels, Huissteden 1450

Wijchen, 6605 HL, Netherlands

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Raymond Koopmans, Professor

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

December 26, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

June 7, 2013

Record last verified: 2011-10

Locations