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Telehealth for Diabetes Self-Management

13 de noviembre de 2007 actualizado por: University of Washington

This study will examine the feasibility and short and-long-term efficacy of a web-based telehealth intervention with community-dwelling older adults who have been diagnosed with type 2 diabetes. Effectiveness will be evaluated using multiple measures within three different domains: 1) physical (glycosylated hemoglobin [HbA1C], weight, and lipid levels); 2) behavioral (monitoring blood glucose levels, feet inspections, diet, and exercise frequency), and 3) psychosocial (depression, quality of life, social support, and adjustment to diabetes).

This is a randomized controlled trial of a web-based telehealth intervention designed to improve self-management behaviors in a group of community dwelling older diabetics. Two groups of participants will be recruited and randomized over a four-month period during years 01 and 02. Participants in the control group will receive standard diabetic care provided by their provider. Participants in the intervention group will receive computer training in the participant's home in how to access and utilize the web-based telehealth study webpage. The intervention will consist of a program designed and delivered via the Internet to improve the participants' diabetes self-management behaviors using behavioral and motivational strategies and cues to modify perceptions of self-efficacy and beliefs regarding the ability to affect the progress of the disease and change personal behavior.

Descripción general del estudio

Descripción detallada

This one year study plans to enroll 62 individuals into two groups. One group will receive the standard diabetic care provided and the second group will receive the standard diabetic care and training on how to use a computer to access the Internet. Participant assignment into either group is random (like flipping a coin). Study procedures will include the completion of questionnaires; a blood pressure reading, weight and a finger prick to obtain a blood sample.

There will be a total of three visits. One visit will occur before the study starts and at a six-month interval during the study period. The time to complete the study procedures by the research staff is approximately 1 to 1½ hours.

  1. Questionnaires: Participants will meet with a research staff person who will ask questions about dietary intake, exercise activity, blood glucose levels, feet inspections, past and current Internet activity, and psychosocial well-being (depression, quality of life, self-efficacy, social support, readiness to change, and adjustment to diabetes). The time estimated for completion is about 45 to 60 minutes.
  2. Physiologic Measures: Participants will have their blood pressures taken, weight measured using a scale, and asked to provide 4-5 drops of blood from the fingertip to measure glycosylated hemoglobin (HbA1c), Cholesterol (HDL:LDL ratio) will be measured to evaluate improvement in short-and-long term (3 months to one year) management of diabetes.
  3. Participants selected to participate in the computer/Internet study group will be contacted by research staff within one month to schedule a time to set-up the study computer equipment and receive computer training. Three 2 hour sessions of computer training over a three-week period in participants' homes will be scheduled. Participants will also be expected to participate in following Internet study procedures, available via the Internet from their homes.

    1. Maintaining a daily personal log of diabetes self care activities (blood sugar readings, diet, exercise, feet inspections, etc.)
    2. Participating in nurse led peer support question and answer chat sessions twice a month.

    d). Read and respond to e-mail sent from the study nurse. e) Read health information on diabetes management, depression, and psychosocial well being that will be provided by the study nurse.

    Computer Training Training will be provided on how to use the computer, access the study web page resources, and participate in the nurse-led peer support group conference forum, use e-mail, and how to prepare and send a daily log of self-management activities (blood sugar monitoring, diet, feet inspections, and exercise). Training will also be provided on how to use the study web site's bulletin board, and the electronic prompt to verify completion of the weekly health reading assignment, and how to develop and post an action plan on-line.

    The amount of time for the above Internet activities will vary depending on participants' degree of interest in accessing the Internet resources provided. Approximately 1-4 hours per week or more will be needed to complete the Internet activities. Participants who are assigned to the intervention group who fail to respond to e-mail or to use any of the intervention resources for a one-week period will be contacted by telephone to determine the reason for not participating in the study activity (technical, knowledge deficit, medical, lack of ability, lack of interest, etc.).

Tipo de estudio

Intervencionista

Inscripción (Actual)

62

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

    • Washington
      • Seattle, Washington, Estados Unidos, 98195
        • University of Washington

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

60 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • diagnosed with Type 2 diabetes (American Diabetes Association criteria), i.e., fasting blood sugar levels of 126 mg/d or non-fasting levels of 200 mg/d when not taking glycemic control medication for diabetes
  • diagnosed with diabetes for at least one year
  • living in a non-institutional home in the community
  • age 60 or older
  • willing to be randomized
  • able to read and write English or have an available caregiver or family member who can provide the necessary language translation.

Exclusion Criteria:

  • moderate to severe cognitive impairment (less than 24 on the Mini Mental State Examination)
  • severe vision impairment (greater than or equal to 9 on the Functional Vision Screening Scale);
  • impairment of Activities of Daily Living (greater than 2 on Katz's Activities of Daily Living Scale);
  • inability to hold and move objects; push buttons or use a trackball or a telephone;
  • the presence of terminal debilitating medical conditions likely to result in death or severe disability prior to completion of the study;
  • severe expressive or receptive communication impairment (inability to communicate will interfere with the administration of outcome measures), or
  • no available phone-line or free electrical outlet

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Subjects randomized into the treatment group received the computer treatment
Web based education format delivered for a six month period

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
glycosylated hemoglobin (A1C) levels.
Periodo de tiempo: one year
one year

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Study participants who receive the web-based telehealth intervention will have fewer depression symptoms and higher quality of life, social support, at post-test (short-term) than participants in the control group.
Periodo de tiempo: 1 year
1 year
Study participants who receive the web-based telehealth intervention will have fewer depression symptoms and higher quality of life, social support, at the 12 month (long-term) follow-up than participants in the control group.
Periodo de tiempo: one year
one year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Gail E Bond, Ph.D, University of Washington
  • Silla de estudio: Fredric Wolf, Ph.D, University of Washington
  • Director de estudio: Martha Price, DNs, University of Washington
  • Silla de estudio: Linda Teri, PhD, University of Washington
  • Silla de estudio: Jerry Palmer, University of Washington

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 septiembre de 2003

Finalización del estudio (Actual)

1 de agosto de 2007

Fechas de registro del estudio

Enviado por primera vez

15 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

15 de septiembre de 2005

Publicado por primera vez (Estimar)

19 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de noviembre de 2007

Última actualización enviada que cumplió con los criterios de control de calidad

13 de noviembre de 2007

Última verificación

1 de noviembre de 2007

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 03-5886-V03
  • 1K01NR008506-03 (Subvención/contrato del NIH 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. .

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