NCT02076555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

4.9 years

First QC Date

February 28, 2014

Last Update Submit

August 7, 2019

Conditions

Diabetes Mellitus

Keywords

diabeteseducationrandomizedprospective

Outcome Measures

Primary Outcomes (1)

  • 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

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

Secondary Outcomes (7)

  • 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

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

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

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

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

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

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

    baseline, 2-week follow-up, 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

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

  • +2 more secondary outcomes

Study Arms (2)

Education - Diabetes and Social Issues

EXPERIMENTAL

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

Behavioral: Education - Diabetes and Social Issues

Waiting-list control group

NO INTERVENTION

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

Interventions

Education - Diabetes and Social IssuesBEHAVIORAL

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.

Education - Diabetes and Social Issues

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Institute of the Diabetes Academy Mergentheim (FIDAM)

Bad Mergentheim, 97980, Germany

Location

Zentrum für Diabetologie Bergedorf

Hamburg, 21029, Germany

Location

Diabeteszentrum Ludwigsburg

Ludwigsburg, 71634, Germany

Location

Diabetologische Schwerpunktpraxis Neuss

Neuss, 41462, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Norbert Hermanns, PhD

    Forschungsinstitut der Diabetes Akademie Mergentheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Research Institut Diabetes Academy Mergentheim

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 3, 2014

Study Start

February 1, 2014

Primary Completion

January 1, 2019

Study Completion

July 1, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

DE(4)