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Effects of Structured Group Education on Quality of Life and Glycemic Control in Type 1 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Structured group education
Individual education
Sponsored by
Azienda Ospedaliero-Universitaria Careggi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • type 1 diabetes

Exclusion Criteria:

  • serious diabetic complications, such as to interfere with physical functioning (e.g., lower limb amputation, renal failure requiring dialysis, blindness)
  • Illiteracy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Structured Group education

    Individual education

    Arm Description

    Six weekly interactive group sessions of 4 hours each, providing information and developing skills for diabetes self-management, including eating habits, food composition, calculation of bolus insulin, information on physical exercise, blood glucose self-monitoring, management of hypoglycemia.

    Usual care (individual consultations as routinely performed)

    Outcomes

    Primary Outcome Measures

    HbA1c (between-group difference in variation from baseline)

    Secondary Outcome Measures

    Quality of life (Well-being enquiry in Diabetics [WED] questionnaire)
    Treatment satisfaction (Diabetes Treatment Satisfaction [DTS] questionnaire)
    Fear of hypoglycemia (Fear of Hypoglycemia [FH-15] questionnaire)
    Severe hypoglycemia (incidence of episodes of hypoglycemia requiring hospitalization and/or help from third parties, self-reported)

    Full Information

    First Posted
    May 4, 2015
    Last Updated
    June 1, 2018
    Sponsor
    Azienda Ospedaliero-Universitaria Careggi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02443532
    Brief Title
    Effects of Structured Group Education on Quality of Life and Glycemic Control in Type 1 Diabetes
    Official Title
    Quality of Life, Treatment Satisfaction, Fear of Hypoglycemia, Eating Habits, Ang Glucose Control in Patients With Type 1 Diabetes: Effects of Structured Group Education Versus Group Care.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Insufficient recruitment
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    January 8, 2018 (Actual)
    Study Completion Date
    January 8, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Ospedaliero-Universitaria Careggi

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients with type 1 diabetes aged 15-65 years without major complications will be randomized either to usual care or to a structured group education program, with 6 four-hour weekly interactive sessions devoted to diabetes management. The principal endpoint will be the variation of HbA1c at 12 months from enrolment. Secondary endpoints will include quality of life, treatment satisfaction, fear of hypoglycemia, incidence of hypoglycemia.
    Detailed Description
    The group intervention consists of interactive sessions for groups of 5-7 patients, dealing with different aspects of management of type 1 diabetes: insulin therapy and hypoglycemia, management of insulin doses, diet, physical exercise, sick days, etc. The intervention is designed for the acquisition of specific skills of self-management. This intervention is provided by a team including physicians, dietitians, and nurses. The control group will receive individual education during routine clinic visits, following usual care, complying with the recommendations of national (Italian) guidelines. HbA1c will be assessed every three months for all the duration of the study. The principal endpoint will be variation from baseline of HbA1c at 12 weeks from the beginning of the intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 1

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Structured Group education
    Arm Type
    Experimental
    Arm Description
    Six weekly interactive group sessions of 4 hours each, providing information and developing skills for diabetes self-management, including eating habits, food composition, calculation of bolus insulin, information on physical exercise, blood glucose self-monitoring, management of hypoglycemia.
    Arm Title
    Individual education
    Arm Type
    Other
    Arm Description
    Usual care (individual consultations as routinely performed)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Structured group education
    Intervention Description
    The group intervention consists of interactive sessions for groups of 5-7 patients, dealing with different aspects of management of type 1 diabetes: insulin therapy and hypoglycemia, management of insulin doses, diet, physical exercise, sick days, etc. The intervention is designed for the acquisition of specific skills of self-management. This intervention is provided by a team including physicians, dietitians, and nurses.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Individual education
    Intervention Description
    Usual care (individual consultations as routinely performed)
    Primary Outcome Measure Information:
    Title
    HbA1c (between-group difference in variation from baseline)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Quality of life (Well-being enquiry in Diabetics [WED] questionnaire)
    Time Frame
    12 months
    Title
    Treatment satisfaction (Diabetes Treatment Satisfaction [DTS] questionnaire)
    Time Frame
    12 months
    Title
    Fear of hypoglycemia (Fear of Hypoglycemia [FH-15] questionnaire)
    Time Frame
    12 months
    Title
    Severe hypoglycemia (incidence of episodes of hypoglycemia requiring hospitalization and/or help from third parties, self-reported)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: type 1 diabetes Exclusion Criteria: serious diabetic complications, such as to interfere with physical functioning (e.g., lower limb amputation, renal failure requiring dialysis, blindness) Illiteracy

    12. IPD Sharing Statement

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