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
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
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
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
NCT ID
NCT02443532
First Posted
May 4, 2015
Last Updated
June 1, 2018
Sponsor
Azienda Ospedaliero-Universitaria Careggi
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
Learn more about this trial
Effects of Structured Group Education on Quality of Life and Glycemic Control in Type 1 Diabetes
We'll reach out to this number within 24 hrs