COVIDNCT04344210
Impact of Tele-interventions During the COVID-19 Pandemic in Patients With Diabetes Mellitus
A study testing Tele-interventions related to diabetes management and mental well-being in people with COVID and Diabetes Mellitus, Type 2, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- Tele-interventions related to diabetes management and mental well-being
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Apr 2020to 20 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90620-170
About this study
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
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.
Read more
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.
- Conditions
- COVID, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Being tested
- Tele-interventions related to diabetes management and mental well-being
- Keywords
- COVID-19, Diabetes Mellitus, Glycemic control, Tele-Intervention, Mental well-being
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, COVID-19, Diabetes Mellitus, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-interventions related to diabetes management and mental well-beingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Tele-Intervention | Experimental | 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 Receives: Behavioral: Tele-interventions related to diabetes management and mental well-being |
| Usual Care | No intervention | Participants will receive the usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in HbA1c levels
Variation in HbA1c levels comparatively between groups after the period of social distancing measures.
Measured: 4 months (or as long as the recommendation of social distancing measures remains)
Secondary outcomes (8)
COVID-19 infection
Confirmation of coronavirus infection by rapid test
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 4 months (or as long as the recommendation of social distancing measures remains)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start17 Apr 2020
- Primary completion20 Sep 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janine Alessi, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344210
- Sponsor's protocol ID
- 2020241093
- Status last verified
- Oct 2020
- First submitted
- 7 Apr 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 36266163Alessi 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.
PubMed 35595850Alessi 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.
PubMed 35197493
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04344210
- Acronym / sponsor ID
- 2020241093
- Conditions
- COVID, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Keywords
- COVID-19, Diabetes Mellitus, Glycemic control, Tele-Intervention, Mental well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tele-Intervention | Experimental | Behavioral: Tele-interventions related to diabetes management and mental well-beingParticipants 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 intervention | –Participants will receive the usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-interventions related to diabetes management and mental well-beingParticipants 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 | Behavioural | Tele-Intervention |
Primary outcome
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.
8 secondary outcomes
COVID-19 infection
Time frame: 4 months (or as long as the recommendation of social distancing measures remains)
Variation in lipid profile
Time frame: 4 months (or as long as the recommendation of social distancing measures remains)
Variation in blood pressure levels
Time frame: 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
Time frame: 4 months (or as long as the recommendation of social distancing measures remains)
Comparison of eating disorders between groups
Time frame: 4 months (or as long as the recommendation of social distancing measures remains)
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)
Comparison of minor psychiatric disorders between groups
Time frame: 4 months (or as long as the recommendation of social distancing measures remains)
Comparison of sleep pattern changes between groups
Time frame: 4 months (or as long as the recommendation of social distancing measures remains)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Derived from this study: PubMed 36266163Franco 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.
- Derived from this study: PubMed 35595850Alessi 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.
- Derived from this study: PubMed 35197493Alessi 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-interventions related to diabetes management and mental well-being in people with COVID and Diabetes Mellitus, Type 2, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in HbA1c levels (time frame: 4 months (or as long as the recommendation of social distancing measures remains)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344210, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.