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ANAIS, a Spanish Version of the DAFNE Programme (ANAIS)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immediate ANAIS
Sponsored by
Rosa María Sánchez Hernández
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring type 1 diabetes, education programme, quality of life, dietary freedom, patient empowerment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Exclusion criteria included severe psychiatric illness, pregnancy, or other circumstances that, according to the investigators' criteria, could interfere with study completion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Immediate ANAIS

    Delayed ANAIS

    Arm Description

    Participants that attend the training course immediately.

    Participants that attend the training course a year later.

    Outcomes

    Primary Outcome Measures

    HbA1c
    Glycated hemoglobin

    Secondary Outcome Measures

    Lipids
    Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein and triglycerides (all are expressed in mg/dl)
    Weight
    weight
    Hypoglycemic events
    Number of hypoglycemic events
    Treatment satisfaction
    Degree of treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Minimum score 0 points, maximum score 36 points. Higher values represent a better outcome.
    Self-defined objectives
    Participants were asked to establish a maximum of 3 personal goals they wanted to achieve related to taking part in the programme
    The quality of life
    Degree of quality of life measured by Spanish version of Jacobson's Diabetes Quality of Life questionnaire (EsDQoL). Minimum score 43 points, maximum score 210 points. Higher values represent a worse outcome.

    Full Information

    First Posted
    October 2, 2018
    Last Updated
    October 4, 2018
    Sponsor
    Rosa María Sánchez Hernández
    Collaborators
    Ana M. Wägner, Dácil Alvarado-Martel, Yaiza López-Plasencia, Armando Carrillo-Domínguez, Julia Rodríguez-Cordero, Francisco J Nóvoa-Mogollón, Angelines Jiménez-Rodríguez
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03699189
    Brief Title
    ANAIS, a Spanish Version of the DAFNE Programme
    Acronym
    ANAIS
    Official Title
    Assessment of ANAIS (Alimentación Normal Con Ajuste de InSulina), a Spanish Version of the DAFNE (Dose Adjustment for Normal Eating) Programme, in Patients With Type 1 Diabetes: a Randomised, Controlled, Parallel Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (Actual)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Rosa María Sánchez Hernández
    Collaborators
    Ana M. Wägner, Dácil Alvarado-Martel, Yaiza López-Plasencia, Armando Carrillo-Domínguez, Julia Rodríguez-Cordero, Francisco J Nóvoa-Mogollón, Angelines Jiménez-Rodríguez

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    ANAIS (Alimentación Normal con Ajuste de InSulina) is a Spanish version of the DAFNE programme, performed in patients with type 1 diabetes. ANAIS is a randomised, controlled, parallel trial. ANAIS is a group-based, therapeutic education programme for type 1 diabetes based on a flexible insulin regime adjusted to the patient's food intake. Participants with type 1 diabetes and an HbA1c between 7 and 10% were recruited from the outpatient clinics in a tertiary care center. They were randomised (opaque, sealed envelopes, 2:1 ratio) to attend the training course immediately (immediate ANAIS) or a year later (delayed ANAIS). The main outcome was HbA1c at one year. Secondary outcomes included lipids, weight, hypoglycemic events, treatment satisfaction, quality of life and self-defined objectives.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 1
    Keywords
    type 1 diabetes, education programme, quality of life, dietary freedom, patient empowerment

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomised, controlled, parallel trial.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate ANAIS
    Arm Type
    Experimental
    Arm Description
    Participants that attend the training course immediately.
    Arm Title
    Delayed ANAIS
    Arm Type
    No Intervention
    Arm Description
    Participants that attend the training course a year later.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Immediate ANAIS
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    HbA1c
    Description
    Glycated hemoglobin
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Lipids
    Description
    Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein and triglycerides (all are expressed in mg/dl)
    Time Frame
    Baseline, 3, 6 and 12 month
    Title
    Weight
    Description
    weight
    Time Frame
    Baseline, 3, 6 and 12 month
    Title
    Hypoglycemic events
    Description
    Number of hypoglycemic events
    Time Frame
    Baseline, 3, 6 and 12 month
    Title
    Treatment satisfaction
    Description
    Degree of treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Minimum score 0 points, maximum score 36 points. Higher values represent a better outcome.
    Time Frame
    Baseline, 3, 6 and 12 month
    Title
    Self-defined objectives
    Description
    Participants were asked to establish a maximum of 3 personal goals they wanted to achieve related to taking part in the programme
    Time Frame
    Baseline, 3, 6 and 12 month
    Title
    The quality of life
    Description
    Degree of quality of life measured by Spanish version of Jacobson's Diabetes Quality of Life questionnaire (EsDQoL). Minimum score 43 points, maximum score 210 points. Higher values represent a worse outcome.
    Time Frame
    Baseline, 3, 6 and 12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Exclusion criteria included severe psychiatric illness, pregnancy, or other circumstances that, according to the investigators' criteria, could interfere with study completion.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    ANAIS, a Spanish Version of the DAFNE Programme

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