Efficacy of Pain Monitor, a Smartphone App for Chronic Pain

NCT03247725 | Completed

• 1 other identifier: UJI_PainMonitor
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The present investigation aims at exploring the effect of including a pain app called Pain Monitor for chronic pain patients' daily monitoring. Three conditions will be set:

1. 1.usual treatment (waiting list)
2. 2.usual treatment + app (without alarms)
3. 3.usual treatment + app (with alarms)

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (4)

• Change in pain intensity

  A numerical rating scale (0-10 range) will be used.

  Dialy during 30 days (app condition) in the app condition (with and without alarm)

• Change in side effects

  A list of the most frequent side effects of pain medication was created

  Dialy during 30 days (app condition) in the app condition (with and without alarm)

• Change in pain intensity

  A numerical rating scale (0-10 range) will be used.

  Twice (first day of study and 30 days after, at the end of study) in the TAU condition

• Change in side effects

  A list of the most frequent side effects of pain medication was created

  Twice (first day of study and 30 days after, at the end of study) in the TAU condition

Secondary Outcomes (14)

• Change in mood

  Dialy during 30 days (app condition) in the app condition (with and without alarm)

• Change in mood

  Twice (first day of study and 30 days after, at the end of study) in the TAU condition

• Change in rescue medication use

  Dialy during 30 days (app condition) in the app condition (with and without alarm)

• Change in rescue medication use

  Twice (first day of study and 30 days after, at the end of study) in the TAU condition

• Change in pain interference

  Dialy during 30 days (app condition) in the app condition (with and without alarm)

Study Arms (3)

Treatment as usual (waiting list)

ACTIVE COMPARATOR

Patients at this condition will receive the usual medical treatment at the pain unit, but they will not be monitored daily using the app.

Other: Treatment as usual (medical)

Treatment as usual + app (without alarm)

EXPERIMENTAL

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. Because alarms will not be generated, physicians will not know if an undesired event is occuring despite the app is actually collecting data.

Other: pain app; Other: Treatment as usual (medical)

Treatment as usual + app (with alarm)

EXPERIMENTAL

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.

Other: pain app; Other: Treatment as usual (medical)

Interventions

pain app OTHER

Pain Monitor app has been developed by a multidisciplinary pain expert panel, including physicians, psychologists, and nurses. Content has been validated in a previous study and usability has been shown to be excellent.

Treatment as usual + app (with alarm); Treatment as usual + app (without alarm)

Treatment as usual (medical) OTHER

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

Treatment as usual (waiting list); Treatment as usual + app (with alarm); Treatment as usual + app (without alarm)

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

Study Sites (1)

Vall d'Hebron Hospital

Barcelona, 08035, Spain

Location

Related Publications (2)

• Rosser BA, Eccleston C. Smartphone applications for pain management. J Telemed Telecare. 2011;17(6):308-12. doi: 10.1258/jtt.2011.101102. Epub 2011 Aug 15.

  PMID: 21844177 BACKGROUND

• Suso-Ribera C, Mesas A, Medel J, Server A, Marquez E, Castilla D, Zaragoza I, Garcia-Palacios A. Improving pain treatment with a smartphone app: study protocol for a randomized controlled trial. Trials. 2018 Feb 27;19(1):145. doi: 10.1186/s13063-018-2539-1.

  PMID: 29482614 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Ángela Mesas Idáñez, MD

  Staff Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will be informed of the condition they have been assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three conditions. Patients will be randomly assigned to one of the three conditions.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 14, 2017
• Study Start: September 1, 2017
• Primary Completion: March 30, 2018
• Study Completion: April 30, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)