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A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care

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ClinicalTrials.gov Identifier: NCT01187069
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : August 20, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

A huge challenge in type 2-diabetes care is how to motivate patients towards health behaviour changes. In Denmark, the tendency is that nurses in general practice provide a large part of type 2 diabetes care.

Observational studies support Self-determination Theory by finding autonomous motivation and perceived competence associated with improved HbA1c-levels in patients with type 2 diabetes. Hence, research is needed to develop and test interventions that are autonomy supportive.

Aim To develop a training course for practice-nurses in autonomy support in patients with type 2 diabetes, and to evaluate the effect on patient outcomes.

Methods The development of the intervention was based on literature research and expert meetings. The intervention is evaluated in a cluster randomised controlled trial with 40 Danish general practices,

  • where nurses, before enrolment in the study, provided consultations to patients with type 2 diabetes,
  • and about 2500 patients with type 2 diabetes, identified in a Diabetes Database.

The patients will be followed 15 months from nurse-participation in the course. Data will be obtained from registers and patient-questionnaires. The hypothesis is that patients with type 2 diabetes regardless of education level, age, and gender will benefit from the intervention.


Condition or disease Intervention/treatment
Type 2 Diabetes Behavioral: Training course for practice nurses in autonomy support

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care. A Pragmatic Cluster Randomised Controlled Trial in Primary Health Care
Study Start Date : August 2009
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Training course for practice nurses in autonomy support Behavioral: Training course for practice nurses in autonomy support
An interactive course consisting of 4X4 hours education in autonomy support over a 6 months period. The main-components in the course are 1) communication skills, 2) introduction to patient work-sheets and 3) a quick up-to-date knowledge about treatment recommendations of type 2 diabetes. Furthermore, the nurses in the intervention-practices receive a half an hour support-visit 4-5 months after the end of the course.
No Intervention: Control
Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice.


Outcome Measures

Primary Outcome Measures :
  1. HbA1c [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ]
    Collected from registers (historical data - not measured as a part of this study)


Secondary Outcome Measures :
  1. HDL-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ]
    Collected from registers (historical data - not measured as a part of this study)

  2. LDL-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ]
    Collected from registers (historical data - not measured as a part of this study)

  3. Perceived autonomy support (HCCQ) [ Time Frame: 15 months from nurse participation in the course ]
    Modified health care climate quastionaire (Self-determination Theory)

  4. Type of motivation (TSRQ) [ Time Frame: 15 months from nurse participation in the course ]
    The treatment self-regulation quastionaire (Self-determination Theory)

  5. Perceived competence (PCS) [ Time Frame: 15 months from nurse participation in the course ]
    perceived competence scale (Self-determination Theory)

  6. Total-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ]
    Collected from registers (historical data - not measured as a part of this study)

  7. Self-rated health (SF-12) [ Time Frame: 15 months from nurse participation in the course ]
  8. Problem Areas In Diabetes scale (PAID) [ Time Frame: 15 months from nurse participation in the course ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The intervention-study comprises 40 general practices were:

    1. more than 50% of the patients with type 2 diabetes, who had participated in diabetes-consultations during the last year from the invitation-date to the project, were seen by a nurse at least once, stated by the practice. The diabetes-consultation should not only include examinations (blood tests and blood pressure measurement), but should also include communication about living with type 2 diabetes ;
    2. enrollment in the project before registration deadline (three weeks after invitation).

Patients with diabetes, alive and affiliated the practices by May 2011, were identified in a a validated diabetes database based on health registers; The national Patient Registry, The national Health Insurance Service registry, the prescription database and the laboratory database in the county.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187069


Locations
Denmark
Department of General Practice, School of Public Health, Aarhus University
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
TrygFonden, Denmark
Sygekassernes Helsefond
Lundbeck Foundation
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01187069     History of Changes
Other Study ID Numbers: 2009-41-3065
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: August 20, 2012
Last Verified: August 2012

Keywords provided by University of Aarhus:
Motivation
patients with type 2 diabetes
practice nurses
general practice
Self-determination Theory

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases