- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07837102
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Akash Gujral
- 전화번호: 5519968100
- 이메일: akash.gujral@hmhn.org
연구 장소
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- 모병
- Hackensack University Medical Center
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연락하다:
- Akash Gujral
-
수석 연구원:
- Jacob Hascalovici, MD
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Paramus, New Jersey, 미국, 07652
- 모병
- Hackensack Meridian Health Neuroscience Institute
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연락하다:
- Akash Gujral
-
수석 연구원:
- Jacob Hascalovici, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Signed informed consent form (ICF)
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Age: Adults aged 18 years or older
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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)
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Have a valid email address
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Have a valid phone number
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Diagnosis Codes:
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Patients with a confirmed diagnosis of Chronic Pain Syndrome based on ICD-10 code G89.4 as primary diagnosis.
■ Including Fibromyalgia M79.7
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Patient with a confirmed secondary diagnosis
- Back Pain M54.5
- Neck Pain M54.2
- Joint Pain M25.5
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Medications: N/A
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Test/Lab results: N/A
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Study sites: Hackensack Meridian Health Neuroscience Institute located at 650 From Road, Suite 506, Paramus, NJ, 07652
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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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Remote monitoring
Remote monitoring using a phone application, an exercise routine, and regular check-ins with a healthcare provider. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Level: Numerical Pain Rating Scale (NPRS)
기간: 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. |
Baseline and once a month for up to 6 months
|
|
Pain Level: Patient Global Impression of Change (PGIC)-pain
기간: 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." |
Baseline and once a month for up to 6 months
|
|
Mood: Patient Health Questionnaire-9 (PHQ-9)
기간: 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. |
Baseline and once a month for up to 6 months
|
|
Mood: Patient Health Questionnaire-2 (PHQ-2)
기간: 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. |
Baseline and once a month for up to 6 months
|
|
Mood: PGIC-mood
기간: 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." |
Baseline and once a month for up to 6 months
|
|
Sleep-Numeric Rating Scale (NRS)
기간: 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. |
Baseline and once a month for up to 6 months
|
|
PGIC-sleep
기간: 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." |
Baseline and once a month for up to 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Multidimensional Scale of Perceived Social Support
기간: Baseline and once a month for up to 6 months
|
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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jacob Hascalovici, MD, Hackensack Meridian Health
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro2025-0258
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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