Motivational interview by practice nurses to improve lifestyle adherence in patients with type 2 diabetes

ISRCTN	ISRCTN68707773
DOI	https://doi.org/10.1186/ISRCTN68707773
Secondary identifying numbers	NTR683

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R.M.E. Jansink
Scientific

Afdeling Kwaliteit van Zorg-117
UMC St Radboud
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Phone	+31 (0)24 3619641
Email	R.Jansink@kwazo.umcn.nl

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Quality of life
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	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 study start date	01/08/2006
Completion date	01/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Afdeling Kwaliteit van Zorg-117

Nijmegen
6500 HB
Netherlands

Sponsor information

University Medical Center St Radboud, Center for Quality of Care Research (WOK) (The Netherlands)
University/education

117 Kwazo
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

"ROR"	https://ror.org/05wg1m734

Funders

Funder type

Research organisation

ZonMw (The Netherlands Organization for Health Research and Development)
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	30/01/2009	Yes	No
Results article	results	28/03/2013	Yes	No
Results article	results	01/06/2013	Yes	No