Type 2 DiabetesNCT01187069
A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care
A study testing Training course for practice nurses in autonomy support in people with Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Training course for practice nurses in autonomy support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of General Practice, School of Public Health, Aarhus University
Aarhus, 8000
About this study
Official title: 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.
Read more
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Training course for practice nurses in autonomy support
- Keywords
- Motivation, patients with type 2 diabetes, practice nurses, general practice, Self-determination Theory
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training course for practice nurses in autonomy supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Training course for practice nurses in autonomy support | Experimental | Not described Receives: Behavioral: Training course for practice nurses in autonomy support |
| Control | No intervention | Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Collected from registers (historical data - not measured as a part of this study)
Measured: Last measurement within 12 months before - and 15 months after nurse participation in the course
Secondary outcomes (8)
HDL-cholesterol
Collected from registers (historical data - not measured as a part of this study)
Measured: Last measurement within 12 months before - and 15 months after nurse participation in the course
LDL-cholesterol
Collected from registers (historical data - not measured as a part of this study)
Measured: Last measurement within 12 months before - and 15 months after nurse participation in the course
Perceived autonomy support (HCCQ)
Modified health care climate quastionaire (Self-determination Theory)
Measured: 15 months from nurse participation in the course
Type of motivation (TSRQ)
The treatment self-regulation quastionaire (Self-determination Theory)
Measured: 15 months from nurse participation in the course
Perceived competence (PCS)
perceived competence scale (Self-determination Theory)
Measured: 15 months from nurse participation in the course
Total-cholesterol
Collected from registers (historical data - not measured as a part of this study)
Measured: Last measurement within 12 months before - and 15 months after nurse participation in the course
Self-rated health (SF-12)
Measured: 15 months from nurse participation in the course
Problem Areas In Diabetes scale (PAID)
Measured: 15 months from nurse participation in the course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Sygekassernes Helsefond, Lundbeck Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187069
- Sponsor's protocol ID
- 2009-41-3065
- Status last verified
- Aug 2012
- First submitted
- 14 Jun 2010
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24798419Juul 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.
PubMed 22111524
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care. A Pragmatic Cluster Randomised Controlled Trial in Primary Health Care
- ClinicalTrials.gov ID
- NCT01187069
- Acronym / sponsor ID
- 2009-41-3065
- Conditions
- Type 2 Diabetes
- Keywords
- Motivation, patients with type 2 diabetes, practice nurses, general practice, Self-determination Theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Sygekassernes Helsefond, Lundbeck Foundation
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training course for practice nurses in autonomy support | Experimental | Behavioral: Training course for practice nurses in autonomy support |
| Control | No intervention | –Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The intervention-study comprises 40 general practices were:
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training course for practice nurses in autonomy supportAn 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. | Behavioural | Training course for practice nurses in autonomy support |
Primary outcome
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)
8 secondary outcomes
HDL-cholesterol
Time frame: Last measurement within 12 months before - and 15 months after nurse participation in the course
LDL-cholesterol
Time frame: Last measurement within 12 months before - and 15 months after nurse participation in the course
Perceived autonomy support (HCCQ)
Time frame: 15 months from nurse participation in the course
Type of motivation (TSRQ)
Time frame: 15 months from nurse participation in the course
Perceived competence (PCS)
Time frame: 15 months from nurse participation in the course
Total-cholesterol
Time frame: Last measurement within 12 months before - and 15 months after nurse participation in the course
Self-rated health (SF-12)
Time frame: 15 months from nurse participation in the course
Problem Areas In Diabetes scale (PAID)
Time frame: 15 months from nurse participation in the course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- Derived from this study: PubMed 24798419Juul 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.
- Derived from this study: PubMed 22111524Juul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training course for practice nurses in autonomy support in people with Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Last measurement within 12 months before - and 15 months after nurse participation in the course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01187069, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2012.