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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02846779
Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)
Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In an era of rapidly growing healthcare costs, due to in large part to the increasing burden and complexity of chronic disease management, targeting outreach to patients who are most likely to benefit from them and tailoring interventions to individual patient needs, represent important opportunities to maximize healthcare value. The Targeted Adherence intervention to Reach Glycemic control with Insulin Therapy for patients with Diabetes (TARGIT-DM) trial is a pragmatic, intention-to-treat, randomized-controlled study that will evaluate the impact of three equivalently-priced strategies to improve insulin persistence and glycosylated hemoglobin [HbA1c] control among patients with diabetes on insulin.
The interventions in each of the three study arms will consist of educational mailings and telephonic pharmacist outreach. The pharmacists will assess and address potential barriers to insulin adherence and optimal glycemic control. The three study arms will employ differ both in regards to which patients are targeted and the intensity of the engagement strategy used. The low intensity intervention in arm 1 will be deployed to all subjects randomized to that arm. The moderate and high intensity interventions will be delivered to focused populations within arms 2 and 3, respectively, as defined by poor disease control and/or predicted risk of non-adherence. The interventions provided in the moderate and high intensity arms will also include feedback to the patient's provider, as needed, and potential enrollment in a text messaging program. Patients in these two arms who are not targeted will receive usual care.
The study population for this trial will consist of members enrolled in commercial insurance provided by Horizon Blue Cross Blue Shield of New Jersey. Insurance claims data will be used to apply the inclusion and exclusion criteria. Eligible patients will be randomized into one of three arms, stratified by baseline availability of HbA1c and a valid telephone number.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Jersey
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Newark, New Jersey, Estados Unidos, 07105-2200
- Horizon Blue Cross Blue Shield of New Jersey
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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:
- Commercially-insured individuals receiving medical and pharmacy health insurance benefits from Horizon Blue Cross Blue Shield of New Jersey
- At least 3 months of continuous enrollment prior to randomization
- At least 1 prescription for basal insulin, 6 months prior to randomization
- Type 2 diabetes diagnosis
Exclusion Criteria:
- Patients with Medicaid or Medicare as primary insurance
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Low intensity
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
|
Low intensity telepharmacy outreach
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Experimental: Moderate intensity
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program.
The pharmacist will also provide limited follow-up with the participant's provider.
Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
|
Moderate intensity telepharmacy outreach
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Experimental: High intensity
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up.
The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist.
Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
|
High intensity telepharmacy outreach
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Insulin Persistence
Periodo de tiempo: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
Percentage of participants who were non-persistent if they did not refill insulin before a set threshold of time over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Glycated Hemoglobin Level (HbA1c)
Periodo de tiempo: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
The percent change in HbA1c level between the latest baseline value to the latest follow up value, among those with at least 1 baseline HbA1c available.
|
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Health Care Spending
Periodo de tiempo: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
Health care spending includes prescription medications, nondrug medical services, and the combination of these two factors over the entire follow-up period
|
From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
Number of Physician Office Visits
Periodo de tiempo: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
Number of all-cause physician office visits over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of Emergency Room Visits
Periodo de tiempo: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
|
Number of all-cause emergency room visits over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of Hospitalizations
Periodo de tiempo: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of All-cause hospitalizations over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Lauffenburger JC, Lewey J, Jan S, Makanji S, Ferro CA, Krumme AA, Lee J, Ghazinouri R, Haff N, Choudhry NK. Effectiveness of Targeted Insulin-Adherence Interventions for Glycemic Control Using Predictive Analytics Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190657. doi: 10.1001/jamanetworkopen.2019.0657. Erratum In: JAMA Netw Open. 2019 Jul 3;2(7):e198448.
- Lewey J, Wei W, Lauffenburger JC, Makanji S, Chant A, DiGeronimo J, Nanchanatt G, Jan S, Choudhry NK. Targeted Adherence Intervention to Reach Glycemic Control with Insulin Therapy for patients with Diabetes (TARGIT-Diabetes): rationale and design of a pragmatic randomised clinical trial. BMJ Open. 2017 Oct 30;7(10):e016551. doi: 10.1136/bmjopen-2017-016551.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016P000648
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
producto fabricado y exportado desde los EE. UU.
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