Chronic PainNCT07837102
Remote Monitoring Using a Digital Platform
A study testing Remote application intervention in people with Chronic Pain, run by Hackensack Meridian Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Remote application intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Dec 2025to 10 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Akash Gujral
Jacob Hascalovici, MD
- Recruiting
Hackensack Meridian Health Neuroscience Institute
Paramus, New Jersey, 07652
Akash Gujral
Jacob Hascalovici, MD
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Being tested
- Remote application intervention
- Keywords
- chronic pain, remote monitoring, home exercise, phone app mediated intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote application interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote monitoring | Experimental | Remote monitoring using a phone application, an exercise routine, and regular check-ins with a healthcare provider. Receives: Behavioral: Remote application intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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."
Measured: Baseline and once a month for up to 6 months
Secondary outcomes (1)
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).
Measured: Baseline and once a month for up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start18 Dec 2025
- Primary completion10 Feb 2028 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Health Foundation
- Responsible party
- Sponsor
- Investigators
- Jacob Hascalovici, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837102
- Sponsor's protocol ID
- Pro2025-0258
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Chronic Pain Management Through Remote Monitoring: A Proof-of-Concept Study Using a Digital Platform
- ClinicalTrials.gov ID
- NCT07837102
- Acronym / sponsor ID
- Pro2025-0258
- Conditions
- Chronic Pain
- Keywords
- chronic pain, remote monitoring, home exercise, phone app mediated intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- New Jersey Health Foundation
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 10 Feb 2028 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote monitoring | Experimental | Behavioral: Remote application interventionRemote monitoring using a phone application, an exercise routine, and regular check-ins with a healthcare provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote application interventionParticipants 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. | Behavioural | Remote monitoring |
Primary outcome
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.
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."
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.
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.
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."
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.
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."
1 secondary outcome
Multidimensional Scale of Perceived Social Support
Time frame: Baseline and once a month for up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob Hascalovici, MD principal investigator
Hackensack Meridian Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote application intervention in people with Chronic Pain, run by Hackensack Meridian Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akash Gujral (5519968100, akash.gujral@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level: Numerical Pain Rating Scale (NPRS) (time frame: Baseline and once a month for up to 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.