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Encouraging Walking in Older Adults

4 de marzo de 2014 actualizado por: University of Pennsylvania
The goal of this pilot randomized controlled trial is to evaluate whether financial incentives and peer networks delivered through a novel computer platform utilizing a digital pedometer-internet interface can effectively encourage sustained increases in walking among older adults.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

This pilot study is a randomized controlled trial of incentive schemes delivered through a novel internet-based platform to promote walking in older adults. The four arms consist of the following: financial incentives, peer network, combined arm (financial incentive & peer network), and control.

Participation in the study will last approximately 26 weeks, including the 2-week run-in period, 4-month intervention period, and 2-month follow-up period.

The primary goals of the study are:

  1. To test the effects of financial incentives on older adults uptake and retention of increased levels of walking.

    Hypothesis1a: Participants receiving financial incentives will increase their number of steps per day more than participants not receiving financial incentives.

  2. To test the effects of connection to a new peer network on older adults uptake and retention of increased levels of walking.

    Hypothesis 2a: Participants connected to a new peer network of other participants will increase their number of steps per day more than participants not connected to a new network.

    Hypothesis 2b: Participants connected to a new peer network of other participants will retain increases in their number of steps per day more than participants not connected to a new network.

  3. To test the combined effects of financial incentives and peer networks on older adults' uptake and retention of increased levels of walking.

    Hypothesis 3a: Participants who receive financial incentives and are connected to a peer network will increase their number of steps per day more than participants who are only connected to a peer network.

    Hypothesis 3b: Participants who receive financial incentives and are connected to a peer network will more effectively maintain increases in number of steps per day as compared with participants who only receive financial incentives.

  4. To develop internet, text and email messaging, and pedometer-internet interface technologies to build peer networks and provide regular feedback to subjects.

Hypothesis 4: The study platform will provide an effective mechanism for subject recruitment, data collection, communication and regular feedback.

Tipo de estudio

Intervencionista

Inscripción (Actual)

92

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

    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • University of Pennsylvania

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

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Adult 65 years of age or older
  • Communicates primarily in English
  • Personal computer with high-speed internet connection and functional Universal Serial Bus (USB) port
  • Able to walk 1/4 mile (i.e., 2 to 3 blocks) without stopping
  • Currently engaging in less than 150 minutes moderate intensity exercise & less than 75 minutes vigorous intensity exercise each week
  • No pedometer use in last 30 days
  • Planning to stay in area for study duration

Exclusion Criteria:

  • Myocardial infarction, stroke, transient ischemic attack, major cardiovascular surgery, deep venous thrombosis, or pulmonary embolus in the last 6 months
  • New York Heart Association Class III or IV heart failure; severe aortic stenosis; history of cardiac arrest, use of cardiac defibrillator; or severe angina
  • Hip fracture, total hip replacement, total knee replacement or spinal surgery in the last 6 months
  • Uncontrolled hypertension
  • Lung disease requiring supplemental oxygen
  • Diabetes mellitus requiring insulin therapy
  • Severe osteoarthritis or rheumatoid arthritis
  • End stage renal disease requiring hemodialysis
  • Movement disorder (e.g., Parkinson's disease)
  • Dementia (e.g., Alzheimers Disease, Lewy-Body Dementia, Multi-Infarct Dementia, Picks Disease, Binswangers Disease, Frontotemporal Dementias, Parkinsons Disease Dementia, Huntingtons Disease, Dementia in HIV/AIDS, Wernicke-Korsakoff syndrome, Creutzfeldt-Jakob disease)
  • Major psychiatric disorder (e.g., schizophrenia or bipolar disorder)
  • Current consumption of ≥ 14 alcoholic drinks per week

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: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Combined Financial Incentive & Peer Network Arm

Daily use of pedometer for 6 months. Walking goal set based on level of walking during 2 week run-in period. Subjects connected with 4 other participants in the same study arm to form a peer network of 5 individuals. Each peer network participant given access to a secure online message board that will allow the 5 participants in each peer network to communicate online. Participants also receive weekly feedback regarding which participants in the peer group achieved their walking goals during the previous week.

Each week, if pedometer is used and walking goal is met for 5 out of 7 days, participant will be entered in lottery with an approximate 3 in 10 chance of winning $50 and an approximate 3 in 100 chance of winning $200.

Financial incentive and peer network terminated after 4 months. Daily use of pedometer continues for an additional 2 months.

Lottery with an approximate 3 in 10 odds of earning $50 and an approximate 3 in 100 odds of earning $200.
Subjects will be connected with 4 other participants in the same study arm to form a peer network of 5 individuals.
Sin intervención: Active Control

Daily use of pedometer for 6 months. Walking goal set based on level of walking during 2 week run-in period. Weekly feedback provided on meeting walking goal - defined as achieving goal number of steps for 5 of 7 days per week.

Subjects in the Control Group will only receive pedometers and weekly feedback on their performance through the same mechanisms and with the same frequency as participants in the other three study arms. There will be no financial incentives or peer networks in this group.

Experimental: Financial Incentive Arm
Daily use of pedometer for 6 months. Walking goal set based on level of walking during 2 week run-in period. Weekly feedback provided on meeting walking goal - defined as achieving goal number of steps for 5 of 7 days per week. Each week, if pedometer is used and walking goal is met for 5 out of 7 days, participant will be entered in lottery with an approximate 3 in 10 chance of winning $50 and an approximate 3 in 100 chance of winning $200. Financial incentive is terminated after 4 months. Daily use of pedometer continues for an additional 2 months.
Lottery with an approximate 3 in 10 odds of earning $50 and an approximate 3 in 100 odds of earning $200.
Experimental: Peer Network Arm

Daily use of pedometer for 6 months. Walking goal set based on level of walking during 2 week run-in period.

Weekly feedback provided on meeting walking goal - defined as achieving goal number of steps for 5 of 7 days per week.

Subjects will be connected with 4 other participants in the same study arm to form a peer network of 5 individuals. Each peer network participant will be given access to a secure online message board that will allow the 5 participants in each peer network to communicate online. All participants in a peer network will receive a list of ways in which his or her new network could support each individual's walking goals. Participants will also receive weekly feedback regarding which participants in the peer group were successful in achieving their walking goals during the previous week.

Peer network is terminated after 4 months. Daily use of pedometer continues for an additional 2 months.

Subjects will be connected with 4 other participants in the same study arm to form a peer network of 5 individuals.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
mean proportion of days that step per day goals were attained
Periodo de tiempo: 16 weeks
16 weeks

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
mean number of steps per day
Periodo de tiempo: 16 weeks
16 weeks
mean proportion of days that step per day goals were attained during follow-up
Periodo de tiempo: 8 weeks
8 weeks

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Jason Karlawish, MD, University of Pennsylvania
  • Director de estudio: Jeffrey T Kullgren, MD, MPH, kullgren@mail.med.edu

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 marzo de 2011

Finalización primaria (Actual)

1 de junio de 2012

Finalización del estudio (Actual)

1 de agosto de 2012

Fechas de registro del estudio

Enviado por primera vez

21 de enero de 2011

Primero enviado que cumplió con los criterios de control de calidad

24 de enero de 2011

Publicado por primera vez (Estimar)

25 de enero de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

5 de marzo de 2014

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

4 de marzo de 2014

Última verificación

1 de febrero de 2014

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 812090
  • RC2AG036592 (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. .

Ensayos clínicos sobre Financial Incentive

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