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A Mobile Intervention to Reduce Pain and Improve Health (MORPH)

29 de diciembre de 2020 actualizado por: Wake Forest University Health Sciences

A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older Adults

Chronic pain contributes to declining health and function in older adults; effects that are intensified by obesity and sedentary (sitting) behavior. The purpose of this study is to develop and test a novel, patient-centered intervention to reduce pain and improve physical function in older, obese adults. The study will utilize a combination of telephone based coaching and smartphone tools to deliver this novel intervention to decrease both body weight and sitting behavior. The long-term goals of this project are to test the efficacy of the intervention and to develop it as a tool for clinicians to provide outside-of-clinic patient-centered support for overweight/obese older adults with chronic pain.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Chronic pain has emerged as an urgent age-related health issue that significantly effects physical functioning and quality of life, with the unfavorable effects worsened by both obesity and sedentary behavior. The annual cost of pain in the United States is nearly 30% higher than the combined costs of cancer and diabetes. In 2016, the NIH called for a National Pain Strategy to: 1) expand non-pharmacological treatment options in older adults, who are particularly susceptible to the side effects of opioid and other pain medications; 2) develop accessible treatments that are tailored to individuals; and 3) increase the development of self-management programs for chronic pain. The purpose of this R-21 is to develop and test the feasibility and acceptability of a novel, patient-centered intervention to reduce chronic pain and improve physical functioning in older adults, leveraging the combination of telecoaching and individually-adaptive mHealth tools to decrease both body mass and sedentary behavior. A pilot randomized controlled trial will be conducted to provide initial evidence for effect sizes (pain and physical function) associated with the proposed intervention, and to estimate the sample size needed for a full scale randomized controlled trial design that compares the effects of the intervention versus usual care on pain ratings and physical function in overweight/obese older adults with chronic pain.

Tipo de estudio

Intervencionista

Inscripción (Actual)

33

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

  • Estados Unidos
    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Wake Forest Baptist Medical Center Pain Center

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 a 79 años (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Own smartphone
  • Pain in 2 of 5 areas (i.e., back, neck, shoulders, hips, knees) on most days during the previous 3 months
  • No contraindication for participation in exercise with approval for participation by their physician
  • Obese (BMI=30-45 kg/m2)
  • Weight-stable (i.e., no weight loss or gain > 5% in the past 6 months)
  • Low-active (i.e., engaging in less than 2 days/week of structured physical activity for at least 20 minutes).
  • Approved for participation by LMC Pain Center Director and Dr. Brooks
  • Willingness to provide consent; Agree to all study procedures and assessments; Able to provide own transportation to study visits
  • Access to home Wi-Fi and smartphone device

Exclusion Criteria:

  • Dependent on cane or walker
  • >1 fall (injurious or non-injurious) in past year
  • Vision insufficient to read a smartphone screen, unable to read
  • Participation in regular resistance training and/or > 20 mins/d of aerobic exercise in past 6 months
  • No contraindication to exercise
  • Unable to walk without assistive devices
  • Cognitive impairment as indicated by a Montreal Cognitive Assessment score < 22
  • Uncontrolled hypertension (>160/90 mmHg);
  • Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen, neurological or hematological disease; cancer requiring treatment in past yr, except non-melanoma skin cancers
  • Regular use of: growth hormones, oral steroids, or prescription osteoporosis medications
  • Current participation in other research study targeting pain, physical activity, or weight loss

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 paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention
Participants receive the MORPH intervention.
Conductual: MORPH
Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.
Sin intervención: Control
The wait list control participants receive usual care and are offered intervention materials on completion of the study.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in PROMIS Pain Intensity Scale
Periodo de tiempo: Baseline to 12 weeks
The Pain Intensity Scale tasks participants with rating how much they hurt on a scale of 1 (had no pain) to 5 (very severe). Final scores are given as T-scores, with higher scores representing worse intensity. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 55 represents a score that is a half-standard deviation about the US national average, and a 40 represents a score that is 1 standard deviation below the national average. Scores were computed using the HealthMeasures.org scoring service as recommended for PROMIS measures.
Baseline to 12 weeks
Change in PROMIS Pain Interference Scale
Periodo de tiempo: Baseline to 12 weeks
The Pain Interference Scale captures the impact of pain on valued areas of an individual's life (e.g., how much did pain interfere with your day to day activities) on a scale of 1 (not at all) to 5 (very much). Final scores are given as T-scores, with higher scores representing worse interference. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 55 represents a score that is a half-standard deviation about the US national average, and a 40 represents a score that is 1 standard deviation below the national average. Scores were computed using the HealthMeasures.org scoring service as recommended for PROMIS measures.
Baseline to 12 weeks
Change in Short Physical Performance Battery
Periodo de tiempo: Baseline to 12 weeks
This test of lower-extremity function consists of 4-m walk at usual pace, a timed repeated chair stand, and 3 increasingly difficult standing balance tests. Each measure is assigned a categorical score ranging from 0 (inability to complete the test) to 4 (best performance) resulting in a final score of 0-12. Higher scores denotes better outcomes.
Baseline to 12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Weight
Periodo de tiempo: Baseline to 12 weeks
Weight will be assessed weekly.
Baseline to 12 weeks
Activity Minutes
Periodo de tiempo: Baseline and Week 12
Activity Minutes will be assessed using ActivPal activity monitors (PAL Technologies Ltd, Glasgow, UK) worn at the thigh for 7 consecutive days. We will assess (a) number of daily minutes spent in light-intensity physical activity as reported by the ActivPal (range: 0-1440, more minutes of light activity are favorable); (b) number of daily minutes spent in moderate-intensity physical activity as reported by the ActivPal (range: 0-1440, more minutes of moderate activity are favorable).
Baseline and Week 12
Sitting Time
Periodo de tiempo: Week 12
daily minutes of sedentary time as recorded on the ActivPALTM 4 device
Week 12
Sit to Stand Transitions
Periodo de tiempo: Baseline and Week 13
Transitions will be assessed using ActivPal activity monitors (PAL Technologies Ltd, Glasgow, UK) worn at the thigh for 7 consecutive days. We will assess number of daily transitions from sitting to non-sitting behavior, captured via the ActivPal inclinometer (range: 0 - infinity; a higher number of transitions are favorable).
Baseline and Week 13
Participant Retention
Periodo de tiempo: Baseline to 12 weeks
The extent to which participants were retained in the study (minimum retention goal of 80%). The number of participants that complete the study over the number that were enrolled.
Baseline to 12 weeks
Utilization of Study Application
Periodo de tiempo: Baseline to 12 weeks
The extent to which participants utilize the study application, as defined by an average weekly use of 7 application accesses per week for the duration of the study period.
Baseline to 12 weeks

Colaboradores e Investigadores

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

Patrocinador

Wake Forest University Health Sciences

Colaboradores

National Institute on Aging (NIA)

Investigadores

  • Investigador principal: Amber K Brooks, MD, Wake Forest University Health Sciences

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.

Publicaciones Generales

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 (Actual)

7 de agosto de 2018

Finalización primaria (Actual)

28 de febrero de 2020

Finalización del estudio (Actual)

28 de febrero de 2020

Fechas de registro del estudio

Enviado por primera vez

14 de diciembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

14 de diciembre de 2017

Publicado por primera vez (Actual)

19 de diciembre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de enero de 2021

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

29 de diciembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB00046364
  • 1R21AG058249-01 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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