The Impact of the COVID-19 Pandemic on Diabetes Management
The Impact of the COVID-19 Pandemic on Diabetes Management (CoDiaM)
| Sponsors |
Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf |
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| Source | Universitätsklinikum Hamburg-Eppendorf | ||||
| 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. |
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| 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. |
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| Overall Status | Not yet recruiting | ||||
| Start Date | April 15, 2021 | ||||
| Completion Date | June 30, 2022 | ||||
| Primary Completion Date | March 31, 2022 | ||||
| Study Type | Observational | ||||
| Primary Outcome |
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| Enrollment | 750 | ||||
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| Intervention |
Intervention Type: Other Intervention Name: No intervention Description: Care as usual Arm Group Label: Patients with diabetes mellitus |
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| Eligibility |
Sampling Method: Probability Sample
Criteria:
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 Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
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| Verification Date |
March 2021 |
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| Responsible Party |
Type: Principal Investigator Investigator Affiliation: Universitätsklinikum Hamburg-Eppendorf Investigator Full Name: Dr. phil. Ingmar Schäfer Investigator Title: Dr. phil. Ingmar Schäfer |
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| Has Expanded Access | No | ||||
| Condition Browse | |||||
| Arm Group |
Label: Patients with diabetes mellitus Description: Approximately 750 patients with diabetes mellitus from 3 GP practices specialized on diabetes treatment |
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| Acronym | CoDiaM | ||||
| Patient Data | No | ||||
| Study Design Info |
Observational Model: Other Time Perspective: Prospective |
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