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Impact of Tele-interventions During the COVID-19 Pandemic in Patients With Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344210
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Janine Alessi, Federal University of Rio Grande do Sul

Study Description
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Brief Summary:

INTRODUCTION In critical situations, such as the current COVID 19 pandemic, themes of fear, uncertainty and stigmatization are common and constitute barriers to appropriate medical and mental health interventions. These challenges, when faced by those who live with a chronic disease, such as diabetes mellitus (DM), can negatively influence quality of life and adherence to treatment, compromising the control of the disease.

OBJECTIVES The present study aims to investigate the effectiveness of a tele-intervention during the COVID-19 pandemic in improving glycemic control, lipid profile, blood pressure levels and parameters of medication adherence, mental well-being and sleep quality in patients with type 1 DM and type 2 DM.

METHODS A randomized clinical trial will be carried out with patients with a previous diagnosis of type 1 DM and type 2 DM, who are registered at the Hospital de Clínicas de Porto Alegre (HCPA). Inclusion criteria will be age greater than or equal to 18 years, collection of HbA1c in the HCPA laboratory in January, February or March 2020 and availability to receive weekly phone calls. Patients will be randomized, stratified by type of diabetes, in two groups: G1: participants will receive a tele-intervention by a case manager weekly to discuss topics related to diabetes management and mental well-being during the social distancing period ; G2: participants will receive the usual care. The primary outcome assessed will be the variation in HbA1c levels comparatively between groups, with or without a tele-guided strategy, after four months of social distancing (or as long as the recommendation of social distancing measures remains). Secondary outcomes will include experiencing confirmation of COVID-19 infection, variation in lipid profile, blood pressure levels and variation in parameters of emotional distress related to diabetes, eating disorders, medication adherence, symptoms minor psychiatric disorders and altered sleep patterns, which will be evaluated with specific and validated scales. According to the sample calculation, 150 patients will be included in the study (92 with type 2 DM and 58 with type 1 DM). Analysis by intention to treat will be performed separately for patients with type 1 DM and with type 2 DM.

SCHEDULE The proposed experiment will start immediately after approval of this project by the research ethics committee. The duration of the proposed intervention is 4 months (or as long as the recommendation of social distancing measures remains. This means that the study may be completed before or after that period, based on national recommendations for social distancing in Brazil), with a data analysis plan and publication of the results until September 2020.


Condition or disease Intervention/treatment Phase
COVID Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Behavioral: Tele-interventions related to diabetes management and mental well-being Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized in two groups: G1: participants will receive a tele-intervention by a case manager weekly to discuss topics related to diabetes management and mental well-being during the quarantine period ; G2: participants will receive the usual care.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Tele-Interventions During the COVID-19 Pandemic on Glycemic Control and Attitude Toward the Disease in Patients With Diabetes Mellitus - A Randomized Clinical Trial
Actual Study Start Date : April 17, 2020
Actual Primary Completion Date : September 20, 2020
Actual Study Completion Date : September 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tele-Intervention
Participants will receive a tele-intervention by a case manager weekly to discuss topics related to diabetes management and mental well-being during the quarantine period
 Behavioral: Tele-interventions related to diabetes management and mental well-being
Participants will receive a tele-intervention by a case manager weekly to discuss topics related to diabetes management and mental well-being during the quarantine period
No Intervention: Usual Care
Participants will receive the usual care


Outcome Measures
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Primary Outcome Measures :
  1. Variation in HbA1c levels [ Time Frame: 4 months (or as long as the recommendation of social distancing measures remains) ]
    Variation in HbA1c levels comparatively between groups after the period of social distancing measures.


Secondary Outcome Measures :
  1. COVID-19 infection [ Time Frame: 4 months (or as long as the recommendation of social distancing measures remains) ]
    Confirmation of coronavirus infection by rapid test

  2. Variation in lipid profile [ Time Frame: 4 months (or as long as the recommendation of social distancing measures remains) ]
    Comparison of the lipid profile of the last year with the lipid profile after the intervention between the groups.

  3. Variation in blood pressure levels [ Time Frame: 4 months (or as long as the recommendation of social distancing measures remains) ]
    Comparison of the blood pressure level of the last consultation with the pressure after the intervention between the groups.

  4. Comparison of emotional distress associated with the routine of living with diabetes after intervention between groups [ Time Frame: 4 months (or as long as the recommendation of social distancing measures remains) ]
    Evaluation of emotional distress associated with the routine of living with diabetes - B-PAID (Brazilian Problem Areas In Diabetes Scale)

  5. Comparison of eating disorders between groups [ Time Frame: 4 months (or as long as the recommendation of social distancing measures remains) ]
    Evaluation of eating disorders - EAT - 26 SCALE (Teste de Atitudes Alimentares)

  6. Comparison of adherence to the proposed clinical treatment between groups [ Time Frame: 4 months (or as long as the recommendation of social distancing measures remains) ]
    Evaluation of adherence to the proposed clinical treatment - SCI R (Self-Care Inventory - revised)

  7. Comparison of minor psychiatric disorders between groups [ Time Frame: 4 months (or as long as the recommendation of social distancing measures remains) ]
    Evaluation of minor psychiatric disorders - SRQ 20 (Self Report Questionnaire)

  8. Comparison of sleep pattern changes between groups [ Time Frame: 4 months (or as long as the recommendation of social distancing measures remains) ]
    Evaluation of sleep pattern changes - MSQ (Mini Sleep Questionnaire)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus or type 2 diabetes mellitus;
  • Age greater than or equal to 18 years;
  • HbA1c assessed in January, February or March 2020;
  • Availability to receive weekly phone calls

Exclusion Criteria:

  • Any severe cognitive limitation that prevents the necessary interaction to carry out this study (advanced dementia, deafness, dysarthria, aphasia);
  • Do not present a telephone record in an electronic medical record;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344210


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90620-170
Sponsors and Collaborators
Federal University of Rio Grande do Sul
More Information
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Responsible Party: Janine Alessi, Master Student, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT04344210    
Other Study ID Numbers: 2020241093
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janine Alessi, Federal University of Rio Grande do Sul:
COVID-19
Diabetes Mellitus
Glycemic control
Tele-Intervention
Mental well-being
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases