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Status unknownNCT03906786Updated Apr 8, 2019

Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.

An interventional study of motivational interviewing in Type1diabetes, sponsored by Hospital Universitario Insular Gran Canaria. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-08.

Sponsored by Hospital Universitario Insular Gran Canaria · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Type 1 diabetes requires a high level of involvement of patients to obtain good control by following complex therapeutic recommendations. Motivational Interviewing has proven to be effective in changing behaviors in sedentary people, with addictions and with obesity.

Our objective is to evaluate the impact of an intervention with Motivational Interviewing in patients with type 1 diabetes, through a randomized controlled clinical trial. At least sixty patients with type 1 diabetes will be included with HbA1c> 8% that will be randomized with a ratio of 1: 1. In the intervention group, Motivational Interviewing will be applied in the routine clinical appointments with the Endocrinologist, while the control group will receive the same visits but in a traditional way.

The primary result will be self-care behaviors according to a validated questionnaire. Secondary outcomes include: HbA1c, number of hypoglycemia, motivation with self-care, self-efficacy, quality of life, compliance with patients' own objectives, lipid profile, weight and blood pressure.

The professionals will be trained in Motivational Interviewing with the objective of favoring the adherence to self-care, the motivation of the patient and improving doctor-patient relationship. They will also be evaluated through a specific questionnaire.

02

Conditions studied

  • Type1diabetes

Keywords

  • self-care
  • motivational interviewing
  • doctor-pacient relationship
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Hospital Universitario Insular Gran Canaria is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with DM1 seen in outpatient clinics of Endocrinology and Nutrition with at least one year of evolution, HbA1c> 8% and / or severe hypoglycemia in the previous 6 months

Exclusion criteria

Exclusion Criteria:

  • Gestion underway or scheduled for the next 9 months. Any circumstance that, in the opinion of the investigators, could interfere with the follow-up of the patient.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    motivacional interviewing group

    Behavioral: motivational interviewing

  • No intervention
    control group

Interventions

  • Behavioralmotivational interviewing

    The intervention will consist of 4 structured medical consultations in the form of a motivational interviewing compared to usual care, covering a 12-month intervention period. In both groups, the frequency of visits (c / 3 months) and the variables collected will be the same.

06

What researchers measure

Primary outcomes

  1. Adherence to self-care behaviors. The Diabetes Self-Care Inventory-Revised

    The validated Spanish version of The Diabetes Self-Care Inventory-Revised version (SCI-R) (18) was used. This inventory consists of 15 items that refer to self-care behaviors in the treatment of diabetes, which are scored on a Likert scale ranging from (1 = "never" to 5 = "always"). The scores are converted with a formula and the responses range from 0-100; higher scores indicate higher levels of self-care

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Complejo Hospitalario Universitario Materno-infantil de Las Palmas
    Las Palmas De Gran Canaria, Las Palmas 35016, Spain
    Recruiting
08

References and documents

Publications

  • Alvarado-Martel D, Boronat M, Alberiche-Ruano MDP, Algara-Gonzalez MA, Ramallo-Farina Y, Wagner AM. Motivational Interviewing and Self-Care in Type 1 Diabetes: A Randomized Controlled Clinical Trial Study Protocol. Front Endocrinol (Lausanne). 2020 Dec 10;11:574312. doi: 10.3389/fendo.2020.574312. eCollection 2020. PubMed 33362714 ↗

Individual participant data

Plan to share: Yes — Anonimized results will be available upon request

Supporting information: Study protocol, Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03906786
Lead sponsor
Hospital Universitario Insular Gran Canaria
Collaborators
Menarini Group
Responsible party
Rosa María Sánchez Hernández (Clinical Doctor, Hospital Universitario Insular Gran Canaria) — Principal investigator
First posted
Apr 8, 2019
Start date
Mar 7, 2019
Primary completion
Sep 30, 2020 (estimated)
Completion
Sep 30, 2020 (estimated)
Last update
Apr 8, 2019

Study contacts

Ana M Wägner
Contact
ana.wagner@ulpgc.es
+34 928453431
Dácil Alvarado
Contact
dacil.alvarado@ulpgc.es
+34 928453431
Ana M Wägner
principal investigator · Hospital Universitario Insular de Gran Canaria

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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