CoDiaM: The Impact of the COVID-19 Pandemic on Diabetes Management

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT04821921
Collaborator
(none)
750
1
17.7
42.4

Study Details

Study Description

Brief Summary

The "CoDiaM study" examines how diabetes management and outcomes are changing during the COVID-19 pandemic and whether these changes are influenced by socio-demographic factors, health literacy, self-efficacy and perceived social support.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

The Covid-19 pandemic created new challenges for patients with diabetes and their treating physicians. In order to protect people from SARS-COV-2 infections, social contacts were reduced by restrictions on many areas of social life. As a side effect, these measures could have also led to changes in the self-management of patients with diabetes mellitus, such as lack of physical exercise, less healthy dietary behavior, and a reduced intensity of medical care. These possible changes may be associated with poorer control of blood glucose, cholesterol, and blood pressure. Therefore, the CoDiaM study will investigate how management and outcomes of diabetes are changing during the pandemic and identify associated factors.

The study is based on data of patients treated in three GP practices specialized on diabetes treatment in Hamburg, Germany. Data collection will include a written patient survey and extraction of clinical data from patient records. The patient's survey includes sociodemographic data and validated instruments to assess diabetes self-management (DSMQ), health literacy (HLS-EU-Q16), self-efficacy (General Self-efficacy scale) and perceived social support (F-SozU K14). Data will be analyzed by descriptive statistics and multivariable, multilevel linear and logistic regression analyses adjusted for possible confounders and random effects on the practice level.

Study Design

Study Type:
Observational
Anticipated Enrollment :
750 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Impact of the COVID-19 Pandemic on Diabetes Management (CoDiaM)
Actual Study Start Date :
Apr 9, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients with diabetes mellitus

Approximately 750 patients with diabetes mellitus from 3 GP practices specialized on diabetes treatment

Other: No intervention
Care as usual

Outcome Measures

Primary Outcome Measures

  1. Hemoglobin A1c (HbA1c) [01.01.2019 to 31.12.2021]

    Data on outcome will be extracted from the GP's patient record

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • being 18 years or older, and

  • having diabetes type 2 or type 1, and

  • having consulted the practice at least once in 2019 AND at least once in 2020

Exclusion Criteria:
  • no capacity to consent (e.g. because of dementia)

  • insufficient German language skills to understand the questions in the questionnaire

  • not able to fill out the questionnaire (e.g. because of blindness)

  • gestational diabetes

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf Hamburg Germany 20246

Sponsors and Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Ingmar Schäfer, Dr. phil., Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. phil. Ingmar Schäfer, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT04821921
Other Study ID Numbers:
  • IPA-2021-01
First Posted:
Mar 30, 2021
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022