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Diabetes and Social Issues: Evaluation of a Diabetes Education Module (PRIMO_Social)

Primary Purpose

Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Education - Diabetes and Social Issues

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring diabetes, education, randomized, prospective

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Intensive insulin treatment
specific interest in "Diabetes and Social Issues"
wish to participate in group education
informed consent
fluent in reading and speaking German language

Exclusion Criteria:

diabetes duration < 4 week
severe organic disease (e.g. terminal renal disease, cancer with poor prognosis)
current treatment of a mental disease
cognitive impairment
dementia
pregnancy

Sites / Locations

Research Institute of the Diabetes Academy Mergentheim (FIDAM)
Zentrum für Diabetologie Bergedorf
Diabeteszentrum Ludwigsburg
Diabetologische Schwerpunktpraxis Neuss

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education - Diabetes and Social Issues

Waiting-list control group

Arm Description

Patients randomized to this arm, will participate immediately in the education module "Diabetes and Social Issues"

Patients in the control group will get the education with the education module after completion of the 6-month follow-up

Outcomes

Primary Outcome Measures

Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up

The Diabetes Empowerment Scale was specifically adjusted to cover the topic "social issues". Psychometric criteria for these adjusted scale were evaluated in an independent study

Secondary Outcome Measures

Change from baseline in problem-specific distress on the adapted Problem Areas in Diabetes (PAID) Scale at the 2-week and 6-month follow-up

The PAID scale was specifically adapted to cover the topic "social issues". Psychometric quality was assessed in an independent study

Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up

HbA1c will be analyzed in a central laboratory.

Change from baseline in health-related quality of life on the EQ-5D at the 2-week and 6-month follow-up

Change from baseline in quality of life on the WHO-5 at the 2-week and 6-month follow-up

Change from baseline in self-efficacy on the General Self-Efficacy Scale (GSE) the 2-week and 6-month follow-up

Change from baseline in general diabetes-distress at the 2-week and 6-month follow-up

Change from baseline in depressive symptoms on the CES-D at the 2-week and 6-month follow-up

Full Information

NCT ID

NCT02076555

First Posted

February 28, 2014

Last Updated

August 7, 2019

Sponsor

Forschungsinstitut der Diabetes Akademie Mergentheim

1. Study Identification

Unique Protocol Identification Number

NCT02076555

Brief Title

Diabetes and Social Issues: Evaluation of a Diabetes Education Module

Acronym

PRIMO_Social

Official Title

A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic "Diabetes and Social Issues" in a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

January 2019 (Actual)

Study Completion Date

July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Forschungsinstitut der Diabetes Akademie Mergentheim

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly developed treatment and education module will be tested compared to a waiting-list control group. The module covers the topic "diabetes and social issues". Primary outcome variable is diabetes-specific empowerment regarding diabetes and social issues. Secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.

Detailed Description

The module consists of one lesson (duration: 90 minutes). The module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by a trained diabetes educator. Patients are randomized either to the immediate participation in the module or to the control group. Control group is a waiting-list control group. Patients in this waiting-list control group get the education after the completion of the 6-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus

Keywords

diabetes, education, randomized, prospective

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

256 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Education - Diabetes and Social Issues

Arm Type

Experimental

Arm Description

Patients randomized to this arm, will participate immediately in the education module "Diabetes and Social Issues"

Arm Title

Waiting-list control group

Arm Type

No Intervention

Arm Description

Patients in the control group will get the education with the education module after completion of the 6-month follow-up

Intervention Type

Behavioral

Intervention Name(s)

Education - Diabetes and Social Issues

Intervention Description

Based on the treatment and education programme PRIMAS a problem-specific education module regarding "Diabetes and Social Issues" was created. The module covers specific and detailed aspects of the topic "social issues" such as driver licence, hypoglycemia when driving, and the pass for severly handicapped persons. With this module, a more comprehensive education of patients with specific interest is possible.

Primary Outcome Measure Information:

Title

Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up

Description

The Diabetes Empowerment Scale was specifically adjusted to cover the topic "social issues". Psychometric criteria for these adjusted scale were evaluated in an independent study

Time Frame

Baseline, 2-week follow-up , 6-month follow-up

Secondary Outcome Measure Information:

Title

Change from baseline in problem-specific distress on the adapted Problem Areas in Diabetes (PAID) Scale at the 2-week and 6-month follow-up

Description

The PAID scale was specifically adapted to cover the topic "social issues". Psychometric quality was assessed in an independent study

Time Frame