- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00214474
Improving Diabetes Efforts Across Language and Literacy (IDEALL)
12 de febrero de 2013 actualizado por: Agency for Healthcare Research and Quality (AHRQ)
The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm randomized controlled trial to explore contextual factors at the patient, clinician, and organizational level of two patient self-management support strategies.
A communication technology-based intervention (automated telephone diabetes management) and an interpersonally-oriented intervention (group medical visits)will be compared to usual care for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net health centers in the University of California, San Francisco (UCSF) Collaborative Research Network.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
See above
Tipo de estudio
Intervencionista
Inscripción (Actual)
339
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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California
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San Francisco, California, Estados Unidos, 94143-1364
- Ucsf Dept of Medicine Box 1364
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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:
- have type 2 diabetes
- have a HbA1c equal to or > 8.0%
- must speak English, Spanish, or Cantonese.
Exclusion Criteria:
- Dementia
- Psychosis/Schizophrenia
- End Stage Renal Disease
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: ATSM Intervention
ATSM Intervention: Automated Telephone Self-Management Support
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Participants randomized to ATSM Intervention received weekly, automated (pre-recorded) telephone calls over 39 weeks (9 months).
Patient responses triggered either immediate, automated health education messages and/or subsequent nurse phone follow-up.
Otros nombres:
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Comparador activo: GMV Intervention
GMV Intervention: Group Medical Visits
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GMV Intervention involved 90-minute monthly sessions over 9 months, involving 6-10 participants, co-facilitated by a primary care physician and health educator.
Otros nombres:
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Sin intervención: Usual Care
Usual Care: Standard care for diabetic patients
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
Periodo de tiempo: Baseline and 1 year
|
The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors.
The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence.
Based on SDSCA measure's author's recommendations, two separate scores can be derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score.
The Diabetes Self-management Behaviors score is used in this study.
For this score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged.
The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in Minutes of Moderate Physical Activity
Periodo de tiempo: Baseline and 1 year
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A measure of patients' physical activity is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do physical activity?
Like walking, house cleaning or gardening."
Number of minutes may range from 0 to 10080, with greater number of minutes indicating more physical activity.
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Baseline and 1 year
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Changes in Minutes of Vigorous Exercise
Periodo de tiempo: Baseline and 1 year
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A measure of patients' vigorous exercise is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do the kind of exercise that makes you breathe hard, such as swimming, walking fast, or biking?"
Number of minutes may range from 0 to 10080, with greater number of minutes indicating more vigorous exercise.
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Baseline and 1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Patient Assessment of Chronic Illness Care (PACIC)
Periodo de tiempo: Baseline and 1 year
|
The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past year that are aligned with the Chronic Care Model.
The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support.
Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care.
Scores are transformed to a 100-point scale and averaged across all items to create a total scale score.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
|
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Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
Periodo de tiempo: Baseline and 1 year
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The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project.
The scale is designed to reflect patients' assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care).
Respondents are asked how difficult over the past year has it been to follow exactly as their doctor who takes care of their diabetes suggested.
Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy.
Total scale score is calculated as the average across all items.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
|
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Changes in Interpersonal Processes of Care (IPC) Scale
Periodo de tiempo: Baseline and 1 year
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The Interpersonal Processes of Care (IPC) captures patient reports of providers' communication over the prior year.
The scale is intended to measure patients' assessment of providers' communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness).
Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score.
Higher total scores indicate better communication.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in the Physical Component Summary of the SF-12 Health Survey
Periodo de tiempo: Baseline and 1 year
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The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes.
The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).
Two summary measures are derived: the Physical and the Mental Health Component Summary.
For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in the Mental Component Summary of the SF-12 Health Survey
Periodo de tiempo: Baseline and 1 year
|
The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes.
The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).
Two summary measures are derived: the Physical and the Mental Health Component Summary.
For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Number of Days Spent in Bed Due to Health Problems
Periodo de tiempo: 1 year
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A measure of patients' functional status is ascertained by asking patients the following question: "In the last 30 days, how many days did your health keep you in bed all or most of the day?" Number of days may range from 0 to 30, with lower number of days indicating better functional status.
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1 year
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Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
Periodo de tiempo: 1 year
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A measure of diabetes interference on patients is ascertained by asking patients the following question: "In the last 12 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?"
Responses consist of 6 possible options: "Always", "Almost Always", "Often", "Sometimes", "Almost Never", and "Never".
These responses are grouped into 2 categories, with one category consisting of "Always", "Almost Always", and "Often" responses while the other category consists of the remaining responses.
The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.
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1 year
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Changes in Hemoglobin A1c Levels
Periodo de tiempo: Baseline and 1 year
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Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way.
This serves as a marker for average blood glucose levels over the previous months prior to the measurement.
Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease.
Change is calculated as 1-year level minus baseline level.
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Baseline and 1 year
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Changes in Systolic Blood Pressure (SBP)
Periodo de tiempo: Baseline and 1 year
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Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body.
Change is calculated as 1-year pressure minus baseline pressure.
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Baseline and 1 year
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Changes in Diastolic Blood Pressure (DBP)
Periodo de tiempo: Baseline and 1 year
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Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood.
Change is calculated as 1-year pressure minus baseline pressure.
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Baseline and 1 year
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Changes in Body Mass Index (BMI)
Periodo de tiempo: Baseline and 1 year
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Body Mass Index (BMI) is a number calculated from a person's weight and height.
BMI is defined as the individual's body mass divided by the square of their height.
The formulae used produce a unit of measure of kg/m2.
BMI provides an indicator of body fatness.
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Baseline and 1 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Dean Schillinger, MD, University of California, San Francisco
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.
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
1 de noviembre de 2002
Finalización primaria (Actual)
1 de noviembre de 2005
Finalización del estudio (Actual)
1 de noviembre de 2005
Fechas de registro del estudio
Enviado por primera vez
19 de septiembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
19 de septiembre de 2005
Publicado por primera vez (Estimar)
22 de septiembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de febrero de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
12 de febrero de 2013
Última verificación
1 de febrero de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R21HS014864-01 (Subvención/Contrato de la AHRQ de EE. UU.)
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. .