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NCT Number: NCT07837102

Remote Monitoring 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack University Medical Center, Hackensack, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote application intervention

Behavioral

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.

Primary outcomes

  1. Pain Level: Numerical Pain Rating Scale (NPRS)

    Time frame: 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.

  2. Pain Level: Patient Global Impression of Change (PGIC)-pain

    Time frame: 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."

  3. Mood: Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 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.

  4. Mood: Patient Health Questionnaire-2 (PHQ-2)

    Time frame: 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.

  5. Mood: PGIC-mood

    Time frame: 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."

  6. Sleep-Numeric Rating Scale (NRS)

    Time frame: 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.

  7. PGIC-sleep

    Time frame: 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."

Secondary outcomes

  1. Multidimensional Scale of Perceived Social Support

    Time frame: 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).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

  • New Jersey Health Foundation

Registry information

Official study title

Optimizing Chronic Pain Management Through Remote Monitoring: A Proof-of-Concept Study Using a Digital Platform

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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