Remote Monitoring Using a Digital Platform

NCT07837102 | Recruiting

• 1 other identifier: Pro2025-0258
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pain

Keywords

chronic pain; remote monitoring; home exercise; phone app mediated intervention

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Multidimensional Scale of Perceived Social Support

  Baseline and once a month for up to 6 months

Study Arms (1)

Remote monitoring

EXPERIMENTAL

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

Behavioral: Remote application intervention

Interventions

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.

Remote monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• New Jersey Health Foundation: collaborator

Study Sites (2)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Hackensack Meridian Health Neuroscience Institute

Paramus, New Jersey, 07652, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Jacob Hascalovici, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akash Gujral

CONTACT

5519968100; akash.gujral@hmhn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): February 10, 2028
• Study Completion (Estimated): February 10, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

US (2)