Remote Monitoring Using a Digital Platform
Optimizing Chronic Pain Management Through Remote Monitoring: A Proof-of-Concept Study Using a Digital Platform
A single site, proof-of-concept prospective behavioral interventional study testing remote monitoring among people living with chronic pain. The study is a single arm study. The duration of the study will be 12-18 months, enrolling 100 and following up to six months post enrollment/ baseline. A convenience sample of 50 patients with CP meeting the inclusion criteria will participate in a 3 to 6 month remote monitoring program utilizing FitCam. Since the time period to conduct this study is 12 months.
FitCam portal/ app will be utilized for the intervention and the outcome will be recorded to observe if remote monitoring has an affect in the health outcome compared to baseline health quality of the patient.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Akash Gujral
- Número de telefone: 5519968100
- E-mail: akash.gujral@hmhn.org
Locais de estudo
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Recrutamento
- Hackensack University Medical Center
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Contato:
- Akash Gujral
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Investigador principal:
- Jacob Hascalovici, MD
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Paramus, New Jersey, Estados Unidos, 07652
- Recrutamento
- Hackensack Meridian Health Neuroscience Institute
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Contato:
- Akash Gujral
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Investigador principal:
- Jacob Hascalovici, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Signed informed consent form (ICF)
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Age: Adults aged 18 years or older
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Ability to comply with the study protocol, including having a smartphone and being able and willing to access the application on a regular basis. To use all functionalities of the application, the user's smartphone must comply with the minimum system requirements (Android version 8.0 or above, iOS version 13.0 or above)
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Have a valid email address
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Have a valid phone number
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Diagnosis Codes:
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Patients with a confirmed diagnosis of Chronic Pain Syndrome based on ICD-10 code G89.4 as primary diagnosis.
■ Including Fibromyalgia M79.7
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Patient with a confirmed secondary diagnosis
- Back Pain M54.5
- Neck Pain M54.2
- Joint Pain M25.5
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Medications: N/A
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Test/Lab results: N/A
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Study sites: Hackensack Meridian Health Neuroscience Institute located at 650 From Road, Suite 506, Paramus, NJ, 07652
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Service: Outpatient
Exclusion Criteria:
- Age: Patients below 18 years of age
- Unable or unwilling to provide informed consent
- Presence of an active diagnosis of a comorbid cognitive impairment such as dementia or mild cognitive impairment
- Lack of access to a smartphone device or inability to demonstrate proficiency in downloading and using mobile applications
- Physical limitations that prevent participation in a basic home exercise program
- Considered by the investigator to have a condition that precludes safe or active participation in the trial
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Remote monitoring
Remote monitoring using a phone application, an exercise routine, and regular check-ins with a healthcare provider. |
Participants will be assigned home exercise programs based on their primary pain location. The study team will provide verbal instructions to delineate the number of times a participant must log pain, mood, and sleep scores in the phone application and how to participate in the home exercise routines. Throughout the study, participants will be contacted by telephone call for a check-in visit. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Level: Numerical Pain Rating Scale (NPRS)
Prazo: Baseline and once a month for up to 6 months
|
The NPRS is an 11-point scale used to measure pain intensity, where 0 signifies no pain and 10 represents the most severe pain imaginable. |
Baseline and once a month for up to 6 months
|
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Pain Level: Patient Global Impression of Change (PGIC)-pain
Prazo: Baseline and once a month for up to 6 months
|
The PGIC-pain is a 7-point scale that reflects a patient's perception of overall progress. Patients indicate their level of change with options ranging from "very much improved" to "very much worse," including intermediate levels such as "much improved," "minimally improved," "no change," "minimally worse," and "much worse." |
Baseline and once a month for up to 6 months
|
|
Mood: Patient Health Questionnaire-9 (PHQ-9)
Prazo: Baseline and once a month for up to 6 months
|
The PHQ-9 is a brief, nine-item assessment tool designed to identify potential depression in patients. It assesses the frequency of depressed mood and anhedonia over the past two weeks. Each item is scored on a scale from 0 to 3, where 0 means "Not at all" and 3 means "Nearly every day", resulting in a total score ranging from 0 to 27. Higher scores indicate a greater likelihood of depression. |
Baseline and once a month for up to 6 months
|
|
Mood: Patient Health Questionnaire-2 (PHQ-2)
Prazo: Baseline and once a month for up to 6 months
|
The Patient Health Questionnaire-2 (PHQ-2) is a brief, two-item screening tool designed to identify potential depression in patients. It assesses the frequency of depressed mood and anhedonia (loss of interest or pleasure) over the past two weeks. Each item is scored on a scale from 0 to 3, where 0 means "not at all" and 3 means "nearly every day," resulting in a total score ranging from 0 to 6. Higher scores indicate a greater likelihood of depression, and a score of 3 or higher typically warrants further evaluation with the PHQ-9 or a more comprehensive clinical assessment. |
Baseline and once a month for up to 6 months
|
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Mood: PGIC-mood
Prazo: Baseline and once a month for up to 6 months
|
The PGIC-mood is a 7-point scale that reflects a patient's perception of overall progress. Patients indicate their level of change with options ranging from "very much improved" to "very much worse," including intermediate levels such as "much improved," "minimally improved," "no change," "minimally worse," and "much worse." |
Baseline and once a month for up to 6 months
|
|
Sleep-Numeric Rating Scale (NRS)
Prazo: Baseline and once a month for up to 6 months
|
The Sleep-NRS is a 0 to 10 scale that assesses sleep quality from the previous night, where 0 represents the poorest sleep and 10 signifies the best possible sleep. It is commonly used to evaluate patients' overall sleep quality. |
Baseline and once a month for up to 6 months
|
|
PGIC-sleep
Prazo: Baseline and once a month for up to 6 months
|
The PGIC-sleep is a 7-point scale that reflects a patient's perception of overall progress. Patients indicate their level of change with options ranging from "very much improved" to "very much worse," including intermediate levels such as "much improved," "minimally improved," "no change," "minimally worse," and "much worse." |
Baseline and once a month for up to 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Multidimensional Scale of Perceived Social Support
Prazo: Baseline and once a month for up to 6 months
|
The Multidimensional Scale of Perceived Social Support (MSPSS) is a widely used and validated questionnaire for assessing social support in research settings based on degree of participation in the program (full = >14 days per month; partial 7-14 days per month; minimal <6 days per month). |
Baseline and once a month for up to 6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jacob Hascalovici, MD, Hackensack Meridian Health
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro2025-0258
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