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

Study Overview
=================
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.

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

Conditions
-----------------
COVID, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Behavioral: Tele-interventions related to diabetes management and mental well-being


Participation Criteria
=================
Eligibility 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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-Intervention<br>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<br>* 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<br>|
| No Intervention: Usual Care<br>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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Diabetes Mellitus, Glycemic control, Tele-Intervention, Mental well-being