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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Training course for practice nurses in autonomy support
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Motivation, patients with type 2 diabetes, practice nurses, general practice, Self-determination Theory

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of General Practice, School of Public Health, Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training course for practice nurses in autonomy support

Control

Arm Description

Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice.

Outcomes

Primary Outcome Measures

HbA1c
Collected from registers (historical data - not measured as a part of this study)

Secondary Outcome Measures

HDL-cholesterol
Collected from registers (historical data - not measured as a part of this study)
LDL-cholesterol
Collected from registers (historical data - not measured as a part of this study)
Perceived autonomy support (HCCQ)
Modified health care climate quastionaire (Self-determination Theory)
Type of motivation (TSRQ)
The treatment self-regulation quastionaire (Self-determination Theory)
Perceived competence (PCS)
perceived competence scale (Self-determination Theory)
Total-cholesterol
Collected from registers (historical data - not measured as a part of this study)
Self-rated health (SF-12)
Problem Areas In Diabetes scale (PAID)

Full Information

First Posted
June 14, 2010
Last Updated
August 17, 2012
Sponsor
University of Aarhus
Collaborators
TrygFonden, Denmark, Sygekassernes Helsefond, Lundbeck Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01187069
Brief Title
A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes 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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
TrygFonden, Denmark, Sygekassernes Helsefond, Lundbeck Foundation

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Motivation, patients with type 2 diabetes, practice nurses, general practice, Self-determination Theory

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training course for practice nurses in autonomy support
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice.
Intervention Type
Behavioral
Intervention Name(s)
Training course for practice nurses in autonomy support
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c
Description
Collected from registers (historical data - not measured as a part of this study)
Time Frame
Last measurement within 12 months before - and 15 months after nurse participation in the course
Secondary Outcome Measure Information:
Title
HDL-cholesterol
Description
Collected from registers (historical data - not measured as a part of this study)
Time Frame
Last measurement within 12 months before - and 15 months after nurse participation in the course
Title
LDL-cholesterol
Description
Collected from registers (historical data - not measured as a part of this study)
Time Frame
Last measurement within 12 months before - and 15 months after nurse participation in the course
Title
Perceived autonomy support (HCCQ)
Description
Modified health care climate quastionaire (Self-determination Theory)
Time Frame
15 months from nurse participation in the course
Title
Type of motivation (TSRQ)
Description
The treatment self-regulation quastionaire (Self-determination Theory)
Time Frame
15 months from nurse participation in the course
Title
Perceived competence (PCS)
Description
perceived competence scale (Self-determination Theory)
Time Frame
15 months from nurse participation in the course
Title
Total-cholesterol
Description
Collected from registers (historical data - not measured as a part of this study)
Time Frame
Last measurement within 12 months before - and 15 months after nurse participation in the course
Title
Self-rated health (SF-12)
Time Frame
15 months from nurse participation in the course
Title
Problem Areas In Diabetes scale (PAID)
Time Frame
15 months from nurse participation in the course

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The intervention-study comprises 40 general practices were: 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 ; 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.
Facility Information:
Facility Name
Department of General Practice, School of Public Health, Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24798419
Citation
Juul L, Maindal HT, Zoffmann V, Frydenberg M, Sandbaek A. Effectiveness of a training course for general practice nurses in motivation support in type 2 diabetes care: a cluster-randomised trial. PLoS One. 2014 May 5;9(5):e96683. doi: 10.1371/journal.pone.0096683. eCollection 2014.
Results Reference
derived
PubMed Identifier
22111524
Citation
Juul L, Maindal HT, Zoffmann V, Frydenberg M, Sandbaek A. A cluster randomised pragmatic trial applying Self-determination theory to type 2 diabetes care in general practice. BMC Fam Pract. 2011 Nov 24;12:130. doi: 10.1186/1471-2296-12-130.
Results Reference
derived

Learn more about this trial

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

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