Clinical trial NCT01187069: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Motivation
patients with type 2 diabetes
practice nurses
general practice
Self-determination Theory
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Sygekassernes Helsefond
name: Lundbeck Foundation
First posted: 2010-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: HbA1c
timeFrame: Last measurement within 12 months before - and 15 months after nurse participation in the course
Secondary outcomes:
measure: HDL-cholesterol
timeFrame: Last measurement within 12 months before - and 15 months after nurse participation in the course
measure: LDL-cholesterol
timeFrame: Last measurement within 12 months before - and 15 months after nurse participation in the course
measure: Perceived autonomy support (HCCQ)
timeFrame: 15 months from nurse participation in the course
measure: Type of motivation (TSRQ)
timeFrame: 15 months from nurse participation in the course
measure: Perceived competence (PCS)
timeFrame: 15 months from nurse participation in the course
measure: Total-cholesterol
timeFrame: Last measurement within 12 months before - and 15 months after nurse participation in the course
measure: Self-rated health (SF-12)
timeFrame: 15 months from nurse participation in the course
measure: Problem Areas In Diabetes scale (PAID)
timeFrame: 15 months from nurse participation in the course
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of General Practice, School of Public Health, Aarhus University
Study officials:
References:
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.
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.