Contact information
Type
Scientific
Primary contact
Dr R.M.E. Jansink
ORCID ID
Contact details
Afdeling Kwaliteit van Zorg-117
UMC St Radboud
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 3619641
R.Jansink@kwazo.umcn.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR683
Study information
Scientific title
Acronym
MILD
Study hypothesis
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
Not provided at time of registration
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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
Secondary outcome measures
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.
Overall trial start date
01/08/2006
Overall trial end date
01/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
700
Participant exclusion criteria
Type 2 diabetes patients who are very ill and patients that are primarily managed in secondary care (e.g. by internist)
Recruitment start date
01/08/2006
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Afdeling Kwaliteit van Zorg-117
Nijmegen
6500 HB
Netherlands
Funders
Funder type
Research organisation
Funder name
ZonMw (The Netherlands Organization for Health Research and Development)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19183462
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23537327
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23659710
Publication citations
-
Protocol
Jansink R, Braspenning J, van der Weijden T, Niessen L, Elwyn G, Grol R, Nurse-led motivational interviewing to change the lifestyle of patients with type 2 diabetes (MILD-project): protocol for a cluster, randomized, controlled trial on implementing lifestyle recommendations., BMC Health Serv Res, 2009, 9, 19, doi: 10.1186/1472-6963-9-19.
-
Results
Jansink R, Braspenning J, Laurant M, Keizer E, Elwyn G, Weijden Tv, Grol R, Minimal improvement of nurses' motivational interviewing skills in routine diabetes care one year after training: a cluster randomized trial., BMC Fam Pract, 2013, 14, 44, doi: 10.1186/1471-2296-14-44.
-
Results
Jansink R, Braspenning J, Keizer E, van der Weijden T, Elwyn G, Grol R, No identifiable Hb1Ac or lifestyle change after a comprehensive diabetes programme including motivational interviewing: a cluster randomised trial., Scand J Prim Health Care, 2013, 31, 2, 119-127, doi: 10.3109/02813432.2013.797178.