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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Akash Gujral
- Numer telefonu: 5519968100
- E-mail: akash.gujral@hmhn.org
Lokalizacje studiów
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New Jersey
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Hackensack, New Jersey, Stany Zjednoczone, 07601
- Rekrutacyjny
- Hackensack University Medical Center
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Kontakt:
- Akash Gujral
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Główny śledczy:
- Jacob Hascalovici, MD
-
Paramus, New Jersey, Stany Zjednoczone, 07652
- Rekrutacyjny
- Hackensack Meridian Health Neuroscience Institute
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Kontakt:
- Akash Gujral
-
Główny śledczy:
- Jacob Hascalovici, MD
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pain Level: Numerical Pain Rating Scale (NPRS)
Ramy czasowe: 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
|
|
Pain Level: Patient Global Impression of Change (PGIC)-pain
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
|
|
Mood: PGIC-mood
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Multidimensional Scale of Perceived Social Support
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Jacob Hascalovici, MD, Hackensack Meridian Health
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Pro2025-0258
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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