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Remote Monitoring Using a Digital Platform

17 september 2026 uppdaterad av: Hackensack Meridian Health

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.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • New Jersey
      • Hackensack, New Jersey, Förenta staterna, 07601
        • Rekrytering
        • Hackensack University Medical Center
        • Kontakt:
          • Akash Gujral
        • Huvudutredare:
          • Jacob Hascalovici, MD
      • Paramus, New Jersey, Förenta staterna, 07652
        • Rekrytering
        • Hackensack Meridian Health Neuroscience Institute
        • Kontakt:
          • Akash Gujral
        • Huvudutredare:
          • Jacob Hascalovici, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Signed informed consent form (ICF)

  • Age: Adults aged 18 years or older

  • 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)

  • Have a valid email address

  • Have a valid phone number

  • Diagnosis Codes:

    • Patients with a confirmed diagnosis of Chronic Pain Syndrome based on ICD-10 code G89.4 as primary diagnosis.

      ■ Including Fibromyalgia M79.7

    • Patient with a confirmed secondary diagnosis

      • Back Pain M54.5
      • Neck Pain M54.2
      • Joint Pain M25.5
  • Medications: N/A

  • Test/Lab results: N/A

  • Study sites: Hackensack Meridian Health Neuroscience Institute located at 650 From Road, Suite 506, Paramus, NJ, 07652

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain Level: Numerical Pain Rating Scale (NPRS)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Multidimensional Scale of Perceived Social Support
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Jacob Hascalovici, MD, Hackensack Meridian Health

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 december 2025

Primärt slutförande (Beräknad)

10 februari 2028

Avslutad studie (Beräknad)

10 februari 2028

Studieregistreringsdatum

Först inskickad

17 september 2026

Först inskickad som uppfyllde QC-kriterierna

17 september 2026

Första postat (Faktisk)

23 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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