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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344210
• Other study ID #: 2020241093
• Status: Completed
• Phase: N/A
• Start date: April 17, 2020
• Est. completion date: September 20, 2020

Study information

• Verified date: October 2020
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: September 20, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• COVID
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	COVID-19 infection	Confirmation of coronavirus infection by rapid test	4 months (or as long as the recommendation of social distancing measures remains)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)