- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02274844
Improving Medication Adherence in the Alabama Black Belt
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Improving medication adherence is one of the greatest challenges in modern medicine. Despite decades of research on the topic, as many as half of patients with chronic diseases are not taking medications as recommended, and costs of nonadherence have been estimated at $290 billion annually. One reason for this persistent finding could be that interventions rarely acknowledge medications within the larger context of the lived experience of illness. Drawing on hundreds of patient interviews, Corbin and Strauss showed that chronic illness is a fundamentally destabilizing influence that forces us to confront the potential limitations of our "new", chronically ill self. Accepting our illness may be a crucial step in embracing medication adherence and other self-management behaviors as ways to restore balance following this disruption. The Corbin and Strauss framework is not often used to develop and test interventions to improve medication adherence, and this is the central objective of this proposal.
Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. Rates of cardiovascular mortality, diabetes and obesity are very high, but resources are scarce and the area's predominately black residents have deep-seated mistrust of the healthcare system (the region includes Tuskegee, site of the infamous syphilis study). This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care. Our Aims are:
Aim 1: With our community partners, using qualitative research methods, build on already developed culturally tailored education material to develop the medication adherence intervention. The intervention will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Activities include conducting focus groups with patients; creating the DVDs and the coaching intervention protocol; training peer coaches; and pilot testing.
Aim 2: Conduct a randomized controlled trial with 500 individuals with type 2 diabetes and medication nonadherence. The trial will compare the effect of usual care and the intervention on medication adherence and physiologic risk factors including A1c, blood pressure and low density lipoprotein cholesterol (primary outcomes), and quality of life and self-efficacy (secondary outcomes).
This innovative approach would be a major shift in how patients are helped in under resourced areas living with chronic diseases commit to taking medications, improving health and eventually reducing health disparities.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35210
- Univeristy of Alabama at Birmingham
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- adults
- type 2 diabetes
- taking medications for diabetes
- medication non adherent
Exclusion Criteria:
- nursing home residence
- plans to move away in the next year
- advanced illnesses such as hemodialysis, cancer or dementia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Peer Coaching
The intervention participants will receive the Living Well with Diabetes Program.
The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
|
The intervention participants will receive the Living Well with Diabetes Program.
The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
|
Sin intervención: Usual Care
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care.
There will be no peer storytelling on these DVDs.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Self Reported Medication Adherence
Periodo de tiempo: Baseline, 6 months
|
Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.
|
Baseline, 6 months
|
Change in Percentage of HbA1c
Periodo de tiempo: Baseline, 6 months
|
Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.
|
Baseline, 6 months
|
Change in Blood Pressure
Periodo de tiempo: Baseline, 6 months
|
2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.
|
Baseline, 6 months
|
Change in Low-Density Lipoprotein (LDL) Cholesterol
Periodo de tiempo: Baseline, 6 months
|
Finger stick, spectrophotometer to measure cholesterol level.
|
Baseline, 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Quality of Life as Assessed With the Short Form 12- Mental Component
Periodo de tiempo: Baseline, 6 months
|
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
|
Baseline, 6 months
|
Change in Quality of Life as Assessed With the Short Form-12- Physical Component
Periodo de tiempo: Baseline, 6 months
|
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
|
Baseline, 6 months
|
Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c
Periodo de tiempo: Baseline, 6 months
|
Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence.
|
Baseline, 6 months
|
Change in Diabetes-Specific Quality of Life
Periodo de tiempo: Baseline, 6 months
|
Diabetes specific quality of life will be assessed using the validated Diabetes Distress Scale.The DDS is a 17-item instrument that measures diabetes-related emotional distress.
Participants rate the degree to which each item is problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem).
A score of 3 or greater = moderate distress.
|
Baseline, 6 months
|
Number of Physician Office Visits 6 Months
Periodo de tiempo: 6 months
|
6 months
|
|
Number of Hospital Stays at 6 Months
Periodo de tiempo: 6 months
|
6 months
|
|
Number of Emergency Visits at 6 Months
Periodo de tiempo: 6 months
|
6 months
|
|
Change in Diabetes Medication Counts
Periodo de tiempo: Baseline, 6 months
|
Change in number of diabetes medications.
|
Baseline, 6 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
Periodo de tiempo: Baseline, 6 months
|
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
|
Baseline, 6 months
|
Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
Periodo de tiempo: Baseline, 6 months
|
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
|
Baseline, 6 months
|
Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
Periodo de tiempo: Baseline, 6 months
|
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
|
Baseline, 6 months
|
Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
Periodo de tiempo: Baseline, 6 months
|
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
|
Baseline, 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Monika M Safford, MD, Weill Medical College of Cornell University
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 (Estimar)
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
Otros números de identificación del estudio
- PCORI-R-AD-1306-03565
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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
-
Meir Medical CenterTerminadoDiabetes mellitus tipo 2 | Diabetes Mellitus, No Insulino Dependiente | Diabetes Mellitus, sobre Tratamiento Hipoglucemiante Oral | Diabetes mellitus tipo adultoIsrael
-
Medical College of WisconsinMedical University of South CarolinaTerminadoDiabetes mellitus | Diabetes mellitus tipo 2 | Diabetes mellitus de inicio en adultos | Diabetes mellitus no insulinodependiente | Diabetes mellitus no insulinodependiente, tipo IIEstados Unidos
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.TerminadoDiabetes Mellitus, Tipo 1 | Diabetes tipo 1 | Diabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes autoinmune | Diabetes Mellitus, Insulino-Dependiente | Diabetes de inicio juvenil | Diabetes Autoinmune | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | Diabetes Mellitus... y otras condicionesEstados Unidos
-
SanofiTerminadoDiabetes Mellitus Tipo 1-Diabetes Mellitus Tipo 2Hungría, Federación Rusa, Alemania, Polonia, Japón, Estados Unidos, Finlandia
-
Guang NingReclutamientoDiabetes mellitus tipo 2 | Diabetes mellitus tipo 1 | Diabetes monogenética | Diabetes pancreatogénica | Diabetes mellitus inducida por fármacos | Otras formas de diabetes mellitusPorcelana
-
Hoffmann-La RocheRoche DiagnosticsTerminadoDiabetes Mellitus Tipo 2, Diabetes Mellitus Tipo 1Alemania
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and Digestive...Activo, no reclutandoDiabetes Mellitus, Tipo 2 | Diabetes Mellitus, Tipo II | Diabetes mellitus, inicio en adultos | Diabetes mellitus, no insulinodependiente | Diabetes Mellitus, No Insulino DependienteEstados Unidos
-
Medical College of WisconsinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)TerminadoDiabetes Mellitus, Tipo 2 | Diabetes Mellitus, Tipo II | Diabetes mellitus, inicio en adultos | Diabetes mellitus, no insulinodependiente | Diabetes Mellitus, No Insulino DependienteEstados Unidos
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)TerminadoDiabetes Mellitus, Tipo 2 | Diabetes Mellitus, Tipo II | Diabetes mellitus, inicio en adultos | Diabetes mellitus, no insulinodependiente | Diabetes Mellitus, No Insulino DependienteEstados Unidos
-
University of California, San FranciscoJuvenile Diabetes Research FoundationTerminadoDiabetes mellitus tipo 1 | Diabetes Mellitus, Tipo I | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | IDDMEstados Unidos, Australia
Ensayos clínicos sobre Living Well with Diabetes Program
-
Central South UniversityAún no reclutando
-
National Cancer Institute (NCI)TerminadoNeoplasias De Células Germinales Y Embrionarias | Neoplasias Pulmonares | Neoplasias Esofágicas | Neoplasias del timo | MesoteliomaEstados Unidos