- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04344210
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
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasil, 90620-170
- Hospital de Clínicas de Porto Alegre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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;
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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
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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
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Sin intervención: Usual Care
Participants will receive the usual care
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Variation in HbA1c levels
Periodo de tiempo: 4 months (or as long as the recommendation of social distancing measures remains)
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Variation in HbA1c levels comparatively between groups after the period of social distancing measures.
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4 months (or as long as the recommendation of social distancing measures remains)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
COVID-19 infection
Periodo de tiempo: 4 months (or as long as the recommendation of social distancing measures remains)
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Confirmation of coronavirus infection by rapid test
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4 months (or as long as the recommendation of social distancing measures remains)
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Variation in lipid profile
Periodo de tiempo: 4 months (or as long as the recommendation of social distancing measures remains)
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Comparison of the lipid profile of the last year with the lipid profile after the intervention between the groups.
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4 months (or as long as the recommendation of social distancing measures remains)
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Variation in blood pressure levels
Periodo de tiempo: 4 months (or as long as the recommendation of social distancing measures remains)
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Comparison of the blood pressure level of the last consultation with the pressure after the intervention between the groups.
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4 months (or as long as the recommendation of social distancing measures remains)
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Comparison of emotional distress associated with the routine of living with diabetes after intervention between groups
Periodo de tiempo: 4 months (or as long as the recommendation of social distancing measures remains)
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Evaluation of emotional distress associated with the routine of living with diabetes - B-PAID (Brazilian Problem Areas In Diabetes Scale)
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4 months (or as long as the recommendation of social distancing measures remains)
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Comparison of eating disorders between groups
Periodo de tiempo: 4 months (or as long as the recommendation of social distancing measures remains)
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Evaluation of eating disorders - EAT - 26 SCALE (Teste de Atitudes Alimentares)
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4 months (or as long as the recommendation of social distancing measures remains)
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Comparison of adherence to the proposed clinical treatment between groups
Periodo de tiempo: 4 months (or as long as the recommendation of social distancing measures remains)
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Evaluation of adherence to the proposed clinical treatment - SCI R (Self-Care Inventory - revised)
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4 months (or as long as the recommendation of social distancing measures remains)
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Comparison of minor psychiatric disorders between groups
Periodo de tiempo: 4 months (or as long as the recommendation of social distancing measures remains)
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Evaluation of minor psychiatric disorders - SRQ 20 (Self Report Questionnaire)
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4 months (or as long as the recommendation of social distancing measures remains)
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Comparison of sleep pattern changes between groups
Periodo de tiempo: 4 months (or as long as the recommendation of social distancing measures remains)
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Evaluation of sleep pattern changes - MSQ (Mini Sleep Questionnaire)
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4 months (or as long as the recommendation of social distancing measures remains)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Neumonía Viral
- Neumonía
- Enfermedades pulmonares
- Enfermedades del sistema endocrino
- COVID-19
- Diabetes mellitus
- Diabetes Mellitus, Tipo 2
- Diabetes Mellitus, Tipo 1
Otros números de identificación del estudio
- 2020241093
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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