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

• ClinicalTrials.gov Identifier: NCT04344210
• Recruitment Status: Completed
• First Posted: April 14, 2020
• Last Update Posted: October 14, 2020
• Sponsor: Federal University of Rio Grande do Sul
• Information provided by (Responsible Party): Janine Alessi, Federal University of Rio Grande do Sul

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Retraction in: Sci Rep. 2022 Mar 11;12(1):4265.

Retraction in: Sci Rep. 2022 Mar 11;12(1):4265

• 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
• 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

• 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:

COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Autoimmune Diseases; Immune System Diseases