This study protocol was developed in accordance with the Recommendations for Interventional Trials 2013 Statement (SPIRIT 2013) and the Consolidated Standards of Reporting Trials statement (CONSORT 2010) when applicable (see checklist in supplementary file).
Study design and setting
This randomized, controlled, single-blind, parallel group clinical trial will be carried out at the Endocrinology and Nutrition service of the Insular University Hospital, Las Palmas de Gran Canaria, a reference center in its area for the care of people with T1D.
Participants and recruitment
A total of 66 people with T1D have been included in the study and will be followed over a period of 16 months. Patients who met the inclusion criteria were informed of the nature of the study and invited to participate. Subsequently, they were recruited by their endocrinologist at the outpatient clinics of the Endocrinology and Nutrition Service of the Insular University Hospital. The recruitment period lasted from March to August 2019.
Diagnosis of T1D, age over 18, at least one year of disease duration, HbA1c>= 8% and/or severe hypoglycemia in the previous six months.
Pregnancy either in progress or scheduled in the following 12 months; any other circumstance that, in the opinion of the investigators, might interfere with the follow-up.
Patients who meet the inclusion criteria receive written information regarding the study and are invited to participate. They are also provided with more information by phone, when they are reminded that the trial will begin at the next scheduled follow-up appointment. At this first appointment, prior to the consultation, the participants sign the informed consent document and fill in a dossier that records all the clinical, sociodemographic and psychosocial variables. These variables are listed in the Measures section below.
Randomization and blinding
The participants are randomly assigned 1:1 to the intervention group or control group. A computer-generated randomization list is used to prepare the labels indicating the assignment of each patient, which is kept in sealed envelopes, numbered consecutively, and stored at the unit. At the time of inclusion of a patient in the study (appointment 1), the appropriate envelope is chosen and opened to show the endocrinologist the treatment assigned. The randomization is stratified by practitioner and the treatment assigned to the first participant each day is applied to all participants scheduled on that day, in order to facilitate the application of the MI and avoid contamination between treatment groups. To limit possible bias, patients are not informed of the assigned treatment. The informed consent document explains that the study will evaluate the effects of the doctor-patient communication, though without going into detail. The researcher who generated the randomization list and prepared the envelopes for the assignment of the treatment group will not be involved in the treatment or evaluation of the participants; likewise, the researchers who will rate MI compliance and analyze the data will be blind to the treatment allocation.
The intervention will consist in the application of MI by the endocrinologist at four follow-up visits, held at four-month intervals.
These visits proceed in the same way as standard appointments, with the addition of this new clinical approach. The visits last approximately 15-20 minutes, in accordance with routine hospital practices.
At each visit, the practitioner applies the four processes of MI (12):
- This first stage serves to establish a therapeutic relationship of trust and mutual respect, if this has not already been achieved.
- This stage is a continuous process of searching for and maintaining direction. The aim is to place the emphasis on the “focus”, i.e., the aspect that the person wants to change. It is not a static process; it may be that in other stages it is necessary to change course and renegotiate the objectives.
- This stage is aimed at eliciting “change talk” from the patient, so that he or she persuades him or herself to change. It begins with the expression of a desire, reason, or need. This stage promotes self-efficacy, one of the most powerful predictors of successful behavior. MI promotes change because it impacts on people’s self-efficacy.
- This stage is characterized by the presence of specific actions. There is less maintenance talk (regarding the behavior to be changed) and more change talk. The person begins to visualize the change and imagines the possible positive results. MI ends when the person commits to the plan.
Before the first appointment and four months after the fourth appointment, the participants complete the questionnaires. In each of the five visits the HbA1c value will be recorded.
A sample of 25 baseline appointments 1 were videotaped in order to assess the application of MI, and serve as ongoing training for the practitioners. A similar procedure will be followed for appointment 4. The practitioners who apply MI have previously received training.
MI is a set of skills designed to help patients overcome their ambivalence to change by evoking motivation and commitment. Professionals can gain expert experience in this method, for example, through an 8-step program (Motivational Interviewing Network of Trainers- MINT), which can be completed in 16 hours.
The three endocrinologists have received structured MI training through theoretical-practical workshops taught by a psychologist with previous training and experience in MI. The workshops, which included didactic instruction and interactive exercises, were divided into two 3-4 hour sessions and two to four additional 60-90 minute encounters. The training started three months before recruitment, continued until the intervention began and addressed the contents established by MINT (table 1). Interactive exercises included interviews conducted with real playing (i.e., colleagues who proposed something they would like to change, in order to make the practice more realistic), as well as role playing (i.e., using cases that are built on the context of T1D). Furthermore, real-patient interviews were overseen by the psychologist, both directly and through visualization of video recordings, and feedback was provided. Finally, all researchers read the MI book “Motivational interviewing: helping people change” (16). In addition, as a reminder, they were given a magnet on which the main tasks associated with MI are printed, to be put up in a visible place in their unit.
To avoid skill erosion and further improve MI performance, regular coaching and feedback-based, post-training sessions were held at baseline and are repeated at 2-3 month intervals during the intervention trial, to adhere to evidence-based practices (33). Individual reading of the book “Motivational Interviewing in Diabetes: facilitating self-care” (34) will complement the post-training sessions.
Patients randomly assigned to the control group will receive their four follow-up visits with standard medical care. The visits will be held at the same intervals as in the intervention group, and will last a similar length of time. At each of the visits the HbA1c will be recorded, and before the first visit and four months after the fourth visit controls will complete the questionnaires in the same way as the intervention group.
Interventions: concomitant care
Participants will continue with their usual follow-up routine for diabetes care. They are not asked for anything additional
Patient and public involvement
The results of the study will be presented to the scientific community at scientific meetings and in a research article. The results will also be disseminated in the local press and on the web page of the research group. Patients will also be informed of the results at the diabetes unit, once the trial has finished.