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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; COVID
• Intervention / Treatment: Behavioral: Tele-interventions related to diabetes management and mental well-being

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-170
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation in HbA1c levels	Variation in HbA1c levels comparatively between groups after the period of social distancing measures.	4 months (or as long as the recommendation of social distancing measures remains)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 infection	Confirmation of coronavirus infection by rapid test	4 months (or as long as the recommendation of social distancing measures remains)
Variation in lipid profile	Comparison of the lipid profile of the last year with the lipid profile after the intervention between the groups.	4 months (or as long as the recommendation of social distancing measures remains)
Variation in blood pressure levels	Comparison of the blood pressure level of the last consultation with the pressure after the intervention between the groups.	4 months (or as long as the recommendation of social distancing measures remains)
Comparison of emotional distress associated with the routine of living with diabetes after intervention between groups	Evaluation of emotional distress associated with the routine of living with diabetes - B-PAID (Brazilian Problem Areas In Diabetes Scale)	4 months (or as long as the recommendation of social distancing measures remains)
Comparison of eating disorders between groups	Evaluation of eating disorders - EAT - 26 SCALE (Teste de Atitudes Alimentares)	4 months (or as long as the recommendation of social distancing measures remains)
Comparison of adherence to the proposed clinical treatment between groups	Evaluation of adherence to the proposed clinical treatment - SCI R (Self-Care Inventory - revised)	4 months (or as long as the recommendation of social distancing measures remains)
Comparison of minor psychiatric disorders between groups	Evaluation of minor psychiatric disorders - SRQ 20 (Self Report Questionnaire)	4 months (or as long as the recommendation of social distancing measures remains)
Comparison of sleep pattern changes between groups	Evaluation of sleep pattern changes - MSQ (Mini Sleep Questionnaire)	4 months (or as long as the recommendation of social distancing measures remains)

Collaborators and Investigators

• Sponsor: Federal University of Rio Grande do Sul

Publications and helpful links

General Publications

• Alessi J, Becker AS, Amaral B, de Oliveira GB, Franco DW, Knijnik CP, Kobe GL, de Brito A, de Carvalho TR, Telo GH, Schaan BD, Telo GH. Type 1 diabetes and the challenges of emotional support in crisis situations: results from a feasibility study of a multidisciplinary teleintervention. Sci Rep. 2022 May 20;12(1):8526. doi: 10.1038/s41598-022-12227-z.
• Alessi J, Becker AS, Amaral B, de Oliveira GB, Franco DW, Knijnik CP, Kobe GL, de Brito A, de Carvalho TR, Telo GH, Schaan BD, Telo GH. Type 1 diabetes and the challenges of emotional support in crisis situations: results from a randomized clinical trial of a multidisciplinary teleintervention. Sci Rep. 2022 Feb 23;12(1):3086. doi: 10.1038/s41598-022-07005-w.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2020
• Primary Completion (Actual): September 20, 2020
• Study Completion (Actual): September 20, 2020

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 11, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; COVID-19; Mental well-being; Glycemic control; Tele-Intervention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2020241093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No