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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Remote application intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Akash Gujral; Phone Number: 5519968100; Email: akash.gujral@hmhn.org

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack University Medical Center
      • Contact: Akash Gujral
      • Principal Investigator: Jacob Hascalovici, MD
    • Paramus, New Jersey, United States, 07652
      • Recruiting
      • Hackensack Meridian Health Neuroscience Institute
      • Contact: Akash Gujral
      • Principal Investigator: Jacob Hascalovici, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Remote monitoring; Remote monitoring using a phone application, an exercise routine, and regular check-ins with a healthcare provider.

Behavioral: Remote application intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level: Numerical Pain Rating Scale (NPRS)	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	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)	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)	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	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)	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multidimensional Scale of Perceived Social Support	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

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Collaborators: New Jersey Health Foundation
• Investigators: Principal Investigator: Jacob Hascalovici, MD, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2025
• Primary Completion (Estimated): February 10, 2028
• Study Completion (Estimated): February 10, 2028

Study Registration Dates

• First Submitted: September 17, 2026
• First Submitted That Met QC Criteria: September 17, 2026
• First Posted (Actual): September 23, 2026

Study Record Updates

• Last Update Posted (Actual): September 23, 2026
• Last Update Submitted That Met QC Criteria: September 17, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; home exercise; remote monitoring; phone app mediated intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: Pro2025-0258

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No