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

29 de dezembro de 2020 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Comportamental: MORPH

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

Estágio

Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

65 anos a 79 anos (Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Tratamento
Alocação: Randomizado
Modelo Intervencional: Atribuição Paralela
Mascaramento: Nenhum (rótulo aberto)

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
Experimental: Intervention Participants receive the MORPH intervention.	Comportamental: 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.
Sem intervenção: Control The wait list control participants receive usual care and are offered intervention materials on completion of the study.

Grupo de Participantes / Braço

Intervenção / Tratamento

Experimental: Intervention

Participants receive the MORPH intervention.

Comportamental: 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.

Sem intervenção: Control

The wait list control participants receive usual care and are offered intervention materials on completion of the study.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change in PROMIS Pain Intensity Scale Prazo: 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 Prazo: 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 Prazo: 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 resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change in Weight Prazo: Baseline to 12 weeks	Weight will be assessed weekly.	Baseline to 12 weeks
Activity Minutes Prazo: 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 Prazo: Week 12	daily minutes of sedentary time as recorded on the ActivPALTM 4 device	Week 12
Sit to Stand Transitions Prazo: 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 Prazo: 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 Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Wake Forest University Health Sciences

Colaboradores

National Institute on Aging (NIA)

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

7 de agosto de 2018

Conclusão Primária (Real)

28 de fevereiro de 2020

Conclusão do estudo (Real)

28 de fevereiro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

14 de dezembro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de dezembro de 2017

Primeira postagem (Real)

19 de dezembro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de janeiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de dezembro de 2020

Última verificação

1 de novembro de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

IRB00046364
1R21AG058249-01 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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