Recruiting

FitCam

Sponsor:

Hackensack Meridian Health

Code:

NCT07837102

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remote application intervention

Study Details

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

Study ID

NCT07837102

Start date

Dec 18, 2025

Status verified date

Sep, 2026

Completion date

Feb 10, 2028

Anticipated

Primary completion date

Feb 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Remote monitoring

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

Interventions

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.

Primary outcome measure

  • Pain Level: Numerical Pain Rating Scale (NPRS) [ Time Frame: Baseline and once a month for up to 6 months ]
  • Pain Level: Patient Global Impression of Change (PGIC)-pain [ Time Frame: Baseline and once a month for up to 6 months ]
  • Mood: Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and once a month for up to 6 months ]
  • Mood: Patient Health Questionnaire-2 (PHQ-2) [ Time Frame: Baseline and once a month for up to 6 months ]
  • Mood: PGIC-mood [ Time Frame: Baseline and once a month for up to 6 months ]
  • Sleep-Numeric Rating Scale (NRS) [ Time Frame: Baseline and once a month for up to 6 months ]
  • PGIC-sleep [ Time Frame: Baseline and once a month for up to 6 months ]

Central Contacts and Locations

Central contacts

Akash Gujral

5519968100akash.gujral@hmhn.org

Locations

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Principal Investigator:

Jacob Hascalovici, MD

Hackensack Meridian Health Neuroscience Institute

Recruiting

Paramus, New Jersey, United States, 07652

Principal Investigator:

Jacob Hascalovici, MD

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.