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

This study has been completed.
Sponsor:
Collaborators:
TrygFonden, Denmark
Sygekassernes Helsefond
Lundbeck Foundation
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01187069
First received: June 14, 2010
Last updated: August 17, 2012
Last verified: August 2012

June 14, 2010
August 17, 2012
August 2009
September 2011   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]
Collected from registers (historical data - not measured as a part of this study)
Same as current
Complete list of historical versions of study NCT01187069 on ClinicalTrials.gov Archive Site
  • HDL-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]
    Collected from registers (historical data - not measured as a part of this study)
  • LDL-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]
    Collected from registers (historical data - not measured as a part of this study)
  • Perceived autonomy support (HCCQ) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
    Modified health care climate quastionaire (Self-determination Theory)
  • Type of motivation (TSRQ) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
    The treatment self-regulation quastionaire (Self-determination Theory)
  • Perceived competence (PCS) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
    perceived competence scale (Self-determination Theory)
  • Total-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]
    Collected from registers (historical data - not measured as a part of this study)
  • Self-rated health (SF-12) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
  • Problem Areas In Diabetes scale (PAID) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]
    Collected from registers (historical data - not measured as a part of this study)
  • LDL-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]
    Collected from registers (historical data - not measured as a part of this study)
  • Perceived autonomy support (HCCQ) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
    Modified health care climate quastionaire (Self-determination Theory)
  • Type of motivation (TSRQ) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
    The treatment self-regulation quastionaire (Self-determination Theory)
  • Perceived competence (PCS) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
    perceived competence scale (Self-determination Theory)
  • Total-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]
    Collected from registers (historical data - not measured as a part of this study)
  • Self-rated health (SF12) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
  • Well-being (WHO-5) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care
A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care. A Pragmatic Cluster Randomised Controlled Trial in Primary Health Care

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Type 2 Diabetes
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.
  • Experimental: Training course for practice nurses in autonomy support
    Intervention: Behavioral: Training course for practice nurses in autonomy support
  • No Intervention: Control
    Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
September 2011   (final data collection date for primary outcome measure)

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.

Both
40 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01187069
2009-41-3065
Yes
University of Aarhus
University of Aarhus
  • TrygFonden, Denmark
  • Sygekassernes Helsefond
  • Lundbeck Foundation
Not Provided
University of Aarhus
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP