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CompletedNCT01297075OutputUpdated May 23, 2014

Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial

An interventional study of Outreach visits in Chronic Disease, sponsored by Research Unit Of General Practice, Copenhagen. Completed at 2 sites in Denmark. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-23.

Sponsored by Research Unit Of General Practice, Copenhagen · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
189
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study summary

The aim of this project is to motivate and support general practice clinics in implementing the visions and recommendations presented in two of the disease specific programmes for chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These programmes describe evidence based treatment and division of tasks between the municipalities, the hospitals and general practice.

The Facilitator Project is funded by The Danish Ministry of Interior and Health.

Read the detailed description

In a cluster randomized trial the investigators will explore the efficacy of up to three outreach visits by specially trained GPs. Efficacy data are obtained by means of questionnaires at regional databases.

02

Conditions studied

  • Chronic Disease

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Keywords

  • Health Services Research
  • Chronic Care
  • Outreach Visits
  • Primary care
  • chronic disease management
03

In context

Chronic Disease

990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.

This study's enrollment of 189 is above the median of 120 across 722 interventional studies indexed under Chronic Disease.

Browse Chronic Disease studies →

Lead sponsor

Research Unit Of General Practice, Copenhagen is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

General Practices working in the capital region in Denmark

Exclusion criteria

Exclusion Criteria:

General Practices where the facilitator works.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
189 participants (actual)

Study arms

  • Experimental
    Outreach visits

    Practices allocated to outreach visits may receive up to three outreach visits in order to motivate and support general practice clinics in implementing two chronic care programmes for chronic obstructive Pulmonary disease and Type 2 diabetes.

    Behavioral: Outreach visits

  • No intervention
    Control (late intervention)

    These practices are allocated to outreach visits after the initial evaluation stops at 12 months.

Interventions

  • BehavioralOutreach visits

    The 16 facilitators in the project attend an educational programme designed to provide them with the necessary skills and tools for the task. The facilitators visit general practice clinics from March 2011 until the end of 2012. Each clinic is offered three visits. The facilitator is to act as a change agent who motivates and helps the clinic team in the process of defining common goals, and choosing the appropriate means for achieving them.

06

What researchers measure

Primary outcomes

  1. Change from baseline at 12 month in Annual systematic chronic disease follow up consultations

    Change in annual systematic chronic disease controls per person affiliated with a primary care at a period at baseline and at 12 month.

    Time frame: Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention)

Secondary outcomes

  1. ICPC diagnosis coding

    Self reports regarding the use of ICPC diagnosis coding for Type 2 Diabetes and Chronic Obstructive Pulmonary Disease.

    Time frame: 12 months

  2. Sentinel Data Capture

    Application for the electronic Sentinel Data Capture module for overview of patients with chronic diseases.

    Time frame: 12 months

  3. Stratification

    The self reported use of stratification as part of primary care management of patients with chronic diseases

    Time frame: 12 months

  4. Change from baseline and at 12 month in practices with low performance on annual systematic chronic disease follow up consultations.

    Reduction in the number of practices with less than 1% annual systematic chronic disease follow up consultations.

    Time frame: Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention)

07

Study locations

2 sites
  • Frans Boch Waldorff
    Copenhagen, Capital Area 1014, Denmark
  • Research Unit of General Practice
    Copenhagen, Capital 1014, Denmark
08

References and documents

Publications

  • Due TD, Thorsen T, Kousgaard MB, Siersma VD, Waldorff FB. The effectiveness of a semi-tailored facilitator-based intervention to optimise chronic care management in general practice: a stepped-wedge randomised controlled trial. BMC Fam Pract. 2014 Apr 9;15:65. doi: 10.1186/1471-2296-15-65. PubMed 24716545 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01297075
Lead sponsor
Research Unit Of General Practice, Copenhagen
Collaborators
Region Capital Denmark
Responsible party
Frans Boch Waldorff (Research Associate professor, Research Unit Of General Practice, Copenhagen) — Principal investigator
First posted
Feb 16, 2011
Start date
Mar 2011
Primary completion
Feb 2012
Completion
Apr 2012
Last update
May 23, 2014

Study contacts

Frans B Waldorff, PhD
principal investigator · Research Unit of General Practice

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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