Utility of a Web-based App for Chronic Pain

NCT03606265 | Completed

• 1 other identifier: GeneralAPP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effectiveness of a web-based app compared to the treatment as usual without an app for the telemonitoring of patients with chronic pain. Two conditions will be set:

1. 1.usual treatment (waiting list)
2. 2.usual treatment + app

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Change in pain intensity by an 11-point Numerical Rating Scale

  Level of pain intensity experienced by the patient. Measure: Brief pain intensity questionnaire. 0-10 range (0=no pain, 10=maximum pain)

  First study day and end of study (Day 1 and day 30)

• Change in side effects

  A list of the most frequent side effects of pain medication has been created. Dicotomous variable. For each side effect: 0=side effect not present; 1=side effect present

  First study day and end of study (Day 1 and day 30)

Secondary Outcomes (4)

• Change in pain interference by an 11-point Numerical Rating Scale

  First study day and end of study (Day 1 and day 30)

• Change in depression

  First study day and end of study (Day 1 and day 30)

• Change in anxiety

  First study day and end of study (Day 1 and day 30)

• Change in pain catastrophizing

  First study day and end of study (Day 1 and day 30)

Study Arms (2)

App+Web

EXPERIMENTAL

Treatment as usual + app Participants at this condition will receive the usual medical treatment for their pain but also they will be monitored daily using the Pain Monitor app. Alarms will be generated in the face of certain preestablished events. Physicians will be asked to call patients and change/stop treatment if an alarm is received.

Device: App+Web

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual (waiting list) Patients at this condition will receive the usual medical treatment at the pain unit, but they will not be monitored daily using the app.

Device: Treatment as usual

Interventions

App+Web DEVICE

Patients will use an app daily twice and physicians will use a website to consult the characteristics of the alarms the app will send them in the presence of an unwanted event

App+Web

Treatment as usual DEVICE

Patients will be offered the usual treatment for their pain, which is not changed by study participation

Treatment as usual

Eligibility Criteria

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

You may qualify if:

• The patient is over 18 years of age
• The patient has a mobile phone with Android operating system
• The patient has the physical ability to use the application
• The patient does not present psychological and / or cognitive alterations or problems with language that make their participation difficult
• The patient voluntarily wants to participate and signs the informed consent

You may not qualify if:

• The patient is under 18 years
• The patient does not have a mobile phone or has a mobile phone in which Android is not the operating system (the app is currently only available for Android for economic reasons)
• The patient does not have the physical capacity to use the application
• The patient does not have the capacity to participate due to psychological and / or cognitive alterations or problems with language
• The patient does not want to participate

Sponsors & Collaborators

• Universitat Jaume I: lead
• HOSPITAL GENERAL UNIVERSITARIO DE CASTELLÓ: collaborator

Study Sites (1)

Hospital General Universitario de Castelló

Castellon, Spain

Location

Related Publications (1)

• Jaen I, Suso-Ribera C, Castilla D, Zaragoza I, Garcia-Palacios A, Gomez Palones JL. Improving chronic pain management with eHealth and mHealth: study protocol for a randomised controlled trial. BMJ Open. 2019 Dec 29;9(12):e033586. doi: 10.1136/bmjopen-2019-033586.

  PMID: 31888939 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 30, 2018
• Study Start: August 15, 2018
• Primary Completion: December 29, 2020
• Study Completion: March 29, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

ES (1)