Remote Monitoring Using a Digital Platform
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Remote application intervention
BehavioralParticipants 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Remote monitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and once a month for up to 6 months2
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."
Time frame
Baseline and once a month for up to 6 months3
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.
Time frame
Baseline and once a month for up to 6 months4
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.
Time frame
Baseline and once a month for up to 6 monthsSecondary 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).
Time frame
Baseline and once a month for up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hackensack Meridian Health
Lead sponsor
New Jersey Health Foundation
Collaborator
Source ClinicalTrials.gov