Efficacy of a Smartphone App for Chronic Pain Management

NCT03678155 | Completed

• 1 other identifier: UJI_PainMonitor_Multicenter
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 8

Brief Summary

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

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

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Change in pain intensity

  A single item using an 11-point numerical rating response scale (0-10 range, with 0 indicating no pain and 10 reflecting worst possible pain) will be used to measure pain intensity

  Daily during 30 days

• Change in side effects

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

  Daily during 30 days

Secondary Outcomes (8)

• Change in sadness

  Daily during 30 days

• Change in happiness

  Daily during 30 days

• Change in anxiety

  Daily during 30 days

• Change in anger

  Daily during 30 days

• Change in rescue medication use

  Daily during 30 days

Study Arms (2)

Treatment as usual + app (without alarm)

ACTIVE COMPARATOR

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

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

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)

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
• Societat Catalana de Dolor: collaborator

Study Sites (8)

Hospital Germans Trias i Pujol

Badalona, Spain

Location

Hospital de Sant Pau i de la Santa Creu

Barcelona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Parc Salut Mar

Barcelona, Spain

Location

Hospital Doctor Trueta

Girona, Spain

Location

Hospital Arnau de Vilanova

Lleida, Spain

Location

Consorci Hospitalari Broggi

Sant Joan Despí, Spain

Location

Hospital Joan XXIII

Tarragona, Spain

Location

Related Links

• Published validation study with the app

MeSH Terms

Conditions

Chronic Pain

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
• Masking Details: Patients will be informed of the condition they have been assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two conditions. Patients will be randomly assigned to one of the two conditions.

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: October 15, 2018
• Primary Completion: February 15, 2020
• Study Completion: December 15, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)