Motivational interview by practice nurses to improve lifestyle adherence in patients with type 2 diabetes
| ISRCTN | ISRCTN68707773 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68707773 |
| Protocol serial number | NTR683 |
| Sponsor | University Medical Center St Radboud, Center for Quality of Care Research (WOK) (The Netherlands) |
| Funder | ZonMw (The Netherlands Organization for Health Research and Development) |
- Submission date
- 29/06/2006
- Registration date
- 29/06/2006
- Last edited
- 09/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Afdeling Kwaliteit van Zorg-117
UMC St Radboud
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 3619641 |
|---|---|
| R.Jansink@kwazo.umcn.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | MILD |
| Study objectives | Adherence level to diabetes guidelines is moderate, especially on educational aspects. Changes in lifestyle is a major element of the patient treatment. Studies on motivational interviewing show promising results among dieticians. There are no primary care studies involving practices nurses. Research questions: 1. What is the effect of structured diabetes care involving a practice nurse, that has been trained on motivational interviewing and equipped with practical tools on diet and exercise programmes compared to usual care on: a. HbA1c b. Diet and exercise c. Other patient's clinical outcomes and professionals' adherence to process indicators based on the diabetes guidelines? 2. What is the incremental cost-effectiveness ratio of our implementation strategy compared to usual care? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Diabetes mellitus type 2 (DM type II) |
| Intervention | Diabetes care according to guidelines focussing on diet and exercise will be implemented using patient-oriented strategy embedded in a structured daily routine. The intervention practitioners have to decide on a schedule on how diabetes care is incorporated into the daily routine. The nurse trained in motivational interviewing (MI) has to activate the commencement of the patient to diet and exercise. The nurse will get a two-day course and follow-up meetings within a supervisory group twice during the first year. The two-day course will include an introduction on MI followed by group discussions and training in the technique using role-play on specific skills including: empowerment, ambivalence, decision balance schedule, stage of change and reflective listening. The practice nurse and patient have to come up with arrangements for the diet and exercise program by making use of MI. The patients will be equipped with a questionnaire and actometer for clinical parameters and short-term targets on diet and/or exercise. The patient should be educated on the interpretation of this information by the practice nurse. The patients in the control group will receive usual care |
| Intervention type | Other |
| Primary outcome measure(s) |
Primary outcome measure will be HbA1c, but main process indicators will consist of changes in exercise as measured by validated actometer and questionnaires as well as diet, as measured by validated self-report forms before and after the intervention |
| Key secondary outcome measure(s) |
Besides the actual paticipation in dieting and exercise programmes, we will determine the intentions of the patients according to the self efficacy (ASE) model. The quality of life of the patients will be measured by EQ-5D.We will also determine the degree of adherence to all other recommendations in the diabetes guidelines by process indicators and measurements of parameters such as, blood pressure and lipids. The focus on diet and exercise should not reduce adherence to other recommendations. In the process evaluation, the feasibility of the strategy will be discussed with all involved parties; and for the practice nurses we will have to explore how capable they were in administering MI. |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 700 |
| Key inclusion criteria | The trial will be held in general practices and all patients with type 2 diabetes, that are <80 years will be included. Patients with HbA1c levels above 8% and body mass index (BMI) above 25 kg/m^2 will also be included. |
| Key exclusion criteria | Type 2 diabetes patients who are very ill and patients that are primarily managed in secondary care (e.g. by internist) |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
6500 HB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/03/2013 | Yes | No | |
| Results article | results | 01/06/2013 | Yes | No | |
| Protocol article | protocol | 30/01/2009 | Yes | No |
