ANAIS, a Spanish Version of the DAFNE Programme

NCT03699189 | Completed DMC

• 1 other identifier: ANAIS
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

ANAIS is a therapeutic education programme for type 1 diabetes based on a flexible insulin regime adjusted to the patient's food intake. Participants are randomised in two groups, to attend the training course immediately (immediate ANAIS) or a year later (delayed ANAIS). The main outcome was HbA1c at one year.

Conditions

Diabetes Mellitus, Type 1

Keywords

type 1 diabetes; education programme; quality of life; dietary freedom; patient empowerment

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Glycated hemoglobin

  1 year

Secondary Outcomes (6)

• Lipids

  Baseline, 3, 6 and 12 month

• Weight

  Baseline, 3, 6 and 12 month

• Hypoglycemic events

  Baseline, 3, 6 and 12 month

• Treatment satisfaction

  Baseline, 3, 6 and 12 month

• Self-defined objectives

  Baseline, 3, 6 and 12 month

Study Arms (2)

Immediate ANAIS

EXPERIMENTAL

Participants that attend the training course immediately.

Behavioral: Immediate ANAIS

Delayed ANAIS

NO INTERVENTION

Participants that attend the training course a year later.

Interventions

Immediate ANAIS BEHAVIORAL

ANAIS is a structured therapeutic education programme aimed at providing the patients with the necessary skills to manage their diabetes independently and confidently. The programme particularly promotes dietary freedom, in an intensive insulin regime, by enabling effective carbohydrate counting and accurate prandial insulin dose adjustment and avoiding hypoglycaemia. ANAIS was organised as a five day (Monday to Friday), seven-hour, outpatient programme using principles of adult education, with explicit learning objectives, in a group setting.

Immediate ANAIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We considered patients to be eligible if they were aged over 18 years, had type 1 diabetes, had an HbA1c between 7-12%, (or HbA1c \< 7% with a history of severe hypoglycemia), duration of diabetes of more than two years without advanced complications and ability to understand written and spoken Spanish.

Sponsors & Collaborators

• Rosa María Sánchez Hernández: lead
• Ana M. Wägner: collaborator
• Dácil Alvarado-Martel: collaborator
• Yaiza López-Plasencia: collaborator
• Armando Carrillo-Domínguez: collaborator
• Julia Rodríguez-Cordero: collaborator
• Francisco J Nóvoa-Mogollón: collaborator
• Angelines Jiménez-Rodríguez: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Patient Participation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Model Details: A randomised, controlled, parallel trial.

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 9, 2018
• Study Start: November 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share