Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
6 de agosto de 2020 actualizado por: Lindsay Mayberry, Vanderbilt University Medical Center
This study evaluates a mobile phone-delivered intervention, called REACH (Rapid Education/Encouragement And Communications for Health), in supporting adults with type 2 diabetes in their self-management relative to a control group.
The goal of this study is to determine if individually tailored content (based on the Information-Motivation-Behavioral Skills Model) delivered to the participant via text messages can improve the participant's glycemic control and adherence to diabetes medications.
We will test whether our intervention improves adherence-related information, motivation, and behavioral skills and whether improving these mechanisms drives improvements in adherence and, in turn, glycemic control.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
512
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Federally Qualified Health Centers and Vanderbilt Primary Care Clinics
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Adults aged 18 years and older
- Individuals who have received a diagnosis for type 2 diabetes mellitus
- Enrolled as a patient at a participating community health center
- Individuals currently being treated with oral and/or injectable diabetes medications
Exclusion Criteria:
- Non-English speakers
- Individuals who report they do not have a cell phone
- Individuals unwilling and/or not able to provide written informed consent
- Individuals with unintelligible speech (e.g., dysarthria)
- Individuals with a severe hearing or visual impairment
- Individuals who report a caregiver administers their diabetes medications Individuals who fail the cognitive screener administered during the baseline survey
- Individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant
- Individuals whose most recent (within 12 months) HbA1c value was 6.8% or greater
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: REACH
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. |
The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
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Experimental: REACH + FAMS
In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. |
Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
The intervention consists of REACH individually-focused text messaging, plus family-focused phone coaching session, goal-focused text messaging, and the option to invite a family member/support person to receive text messaging.
Otros nombres:
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Comparador activo: Helpline and A1c results
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. |
Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
Periodo de tiempo: Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful
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Baseline, 3 months, 6 months, 12 months, 15 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Self-reported Medication Adherence
Periodo de tiempo: Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by the Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale; response options are days in the last week ranging from 0 to 7, with 7 representing perfect adherence
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Self-reported Medication Adherence
Periodo de tiempo: Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D); reverse coded such that higher scores indicate better adherence on a scale from 11 to 44
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Baseline, 3 months, 6 months, 12 months, 15 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Adherence to Dietary Behavior
Periodo de tiempo: Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by the Personal Diabetes Questionnaire diet subscale "Use of information for decision making"; possible range 1-6, higher indicates more use of dietary information (better)
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Adherence to Dietary Behavior
Periodo de tiempo: Baseline, 3 months, 6 months, 12 months, 15 months
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Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse)
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Physical Activity
Periodo de tiempo: Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by International Physical Activity Questionnaire-Short form [metabolic equivalent minutes (MET-minutes) per week] where more MET-minutes per week indicates more physical activity
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control
Periodo de tiempo: Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses.
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Baseline, 3 months, 6 months, 12 months, 15 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Lindsay S Mayberry, MS, PhD, Vanderbilt University Medical Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Nelson LA, Mayberry LS, Wallston K, Kripalani S, Bergner EM, Osborn CY. Development and Usability of REACH: A Tailored Theory-Based Text Messaging Intervention for Disadvantaged Adults With Type 2 Diabetes. JMIR Hum Factors. 2016 Sep 8;3(2):e23. doi: 10.2196/humanfactors.6029.
- Nelson LA, Wallston KA, Kripalani S, Greevy RA Jr, Elasy TA, Bergner EM, Gentry CK, Mayberry LS. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 10;7(4):e92. doi: 10.2196/resprot.9443.
- Roddy MK, Mayberry LS, Nair D, Cavanaugh KL. Exploring mHealth potential to improve kidney function: secondary analysis of a randomized trial of diabetes self-care in diverse adults. BMC Nephrol. 2022 Aug 10;23(1):280. doi: 10.1186/s12882-022-02885-6.
- Mayberry LS, Bergner EM, Harper KJ, Laing S, Berg CA. Text messaging to engage friends/family in diabetes self-management support: acceptability and potential to address disparities. J Am Med Inform Assoc. 2019 Oct 1;26(10):1099-1108. doi: 10.1093/jamia/ocz091.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de mayo de 2016
Finalización primaria (Actual)
4 de junio de 2019
Finalización del estudio (Actual)
4 de junio de 2019
Fechas de registro del estudio
Enviado por primera vez
9 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
31 de marzo de 2015
Publicado por primera vez (Estimar)
6 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de agosto de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
6 de agosto de 2020
Última verificación
1 de agosto de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 140562
- 1R01DK100694-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data collected during the trial will be de-identified and made available following publication of the 15-month trial results to researchers who provide a methodologically sound proposal.
Marco de tiempo para compartir IPD
Beginning 6 months after final trial results publication.
No end date.
Criterios de acceso compartido de IPD
Approval of a proposal by the study PI.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Diabetes Mellitus, Tipo 2
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Instituto Nacional de Ciencias Medicas y Nutricion...Activo, no reclutando
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ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi Demirsoy... y otros colaboradoresAún no reclutandoDiabetes tipo 2 | Diabetes mellitus tipo 2Turquía (Türkiye)
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Endogenex, Inc.Aún no reclutandoDiabetes Mellitus, Tipo 2 | Diabetes | Diabetes mellitus tipo 2 | Diabetes tipo 2 | Diabetes tipo 2
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University of SalamancaUniversity of Salamanca; Instituto Piaget; Escola Superior de Tecnologia da Saúde...Inscripción por invitaciónDiabetes mellitus tipo 2 | Envejecimiento | Hiperglucemia por diabetes mellitus tipo 2Portugal
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Endogenex, Inc.Aún no reclutandoDiabetes Mellitus, Tipo 2 | Diabetes | Diabetes tipo 2 | Diabetes mellitus tipo 2 (DM2) | Diabetes tipo 2
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El Katib HospitalAún no reclutandoDiabetes mellitus tipo 2 (DM2)
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He Eye HospitalAún no reclutando
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Diabetes Solutions InternationalDexCom, Inc.; Tidepool; MAVEN ProjectReclutamientoDiabetes mellitus tipo 2 (DM2)Estados Unidos
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Ohio State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Aún no reclutandoDM2 (Diabetes Mellitus Tipo 2)Estados Unidos
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Global Institute of Stem Cell Therapy and ResearchAún no reclutando
Ensayos clínicos sobre REACH
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Tufts Medical CenterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Activo, no reclutandoFatiga | Lupus eritematoso sistémicoEstados Unidos
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University of California, DavisTerminadoCuidadores familiaresVietnam
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University of MinnesotaReclutamientoUso de sustancias | El consumo de drogasEstados Unidos
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University of Central FloridaAdventHealthTerminadoDemencia | Enfermedad de AlzheimerEstados Unidos
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University of Southern CaliforniaUniversity of California, Los Angeles; University of California, IrvineReclutamientoInfarto de miocardio | Carrera | HipertensiónEstados Unidos
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Salem Veterans Affairs Medical CenterUnited States Department of Defense; Virginia Polytechnic Institute and State... y otros colaboradoresTerminadoDemenciaEstados Unidos
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Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Activo, no reclutandoAdherencia a la medicación | Diabetes tipo 2 (aparición en adultos)Estados Unidos
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University of California, DavisNational Institute on Aging (NIA); University of Minnesota; National Geriatric...Terminado
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City University of Hong KongStanford University; Harvard UniversityTerminadoBienestar de la salud mentalColombia, Indonesia, Sudáfrica, Ucrania
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Wuerzburg University HospitalUniversity of Leipzig; University of Wuerzburg; Campus Bad Neustadt; Klinikum Aschaffenburg-Alzenau y otros colaboradoresTerminadoDepresión | Calidad de vida | AnsiedadAlemania