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
1 other identifier
interventional
149
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2020
CompletedFirst Posted
Study publicly available on registry
April 14, 2020
CompletedStudy Start
First participant enrolled
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2020
CompletedOctober 14, 2020
October 1, 2020
5 months
April 7, 2020
October 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
COVID-19 infection
4 months (or as long as the recommendation of social distancing measures remains)
Variation in lipid profile
4 months (or as long as the recommendation of social distancing measures remains)
Variation in blood pressure levels
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
4 months (or as long as the recommendation of social distancing measures remains)
Comparison of eating disorders between groups
4 months (or as long as the recommendation of social distancing measures remains)
- +3 more secondary outcomes
Study Arms (2)
Tele-Intervention
EXPERIMENTALParticipants 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
Usual Care
NO INTERVENTIONParticipants will receive the usual care
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90620-170, Brazil
Related Publications (3)
Franco DW, Alessi J, de Carvalho TR, Kobe GL, Oliveira GB, Knijnik CP, Amaral B, Becker AS, Schaan BD, Telo GH. The impact of a telehealth intervention on the metabolic profile of diabetes mellitus patients during the COVID-19 pandemic - A randomized clinical trial. Prim Care Diabetes. 2022 Dec;16(6):745-752. doi: 10.1016/j.pcd.2022.09.011. Epub 2022 Sep 30.
PMID: 36266163DERIVEDAlessi 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.
PMID: 35595850DERIVEDAlessi 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.
PMID: 35197493DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master Student
Study Record Dates
First Submitted
April 7, 2020
First Posted
April 14, 2020
Study Start
April 17, 2020
Primary Completion
September 20, 2020
Study Completion
September 20, 2020
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE