Utility of a Web-based App for Chronic Pain
The Effectiveness of a Web-based App for the Treatment of Chronic Pain
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:
- usual treatment (waiting list)
- usual treatment + app
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Castellón De La Plana, Spain
- Hospital General Universitario de Castelló
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: App+Web
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.
|
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
|
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ACTIVE_COMPARATOR: Treatment as usual
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.
|
Patients will be offered the usual treatment for their pain, which is not changed by study participation
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain intensity by an 11-point Numerical Rating Scale
Time Frame: First study day and end of study (Day 1 and day 30)
|
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
Time Frame: First study day and end of study (Day 1 and day 30)
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain interference by an 11-point Numerical Rating Scale
Time Frame: First study day and end of study (Day 1 and day 30)
|
Interference of pain with patient's life.
Brief Pain Inventory questionnaire.
0-10 range (0=no interference, 10=maximum interference)
|
First study day and end of study (Day 1 and day 30)
|
|
Change in depression
Time Frame: First study day and end of study (Day 1 and day 30)
|
Hospital Anxiety and Depression Scale.
Item scoring is 0 to 3. Response anchors vary across items.
Subscale range is 0-21.
Higher scores indicate more depression
|
First study day and end of study (Day 1 and day 30)
|
|
Change in anxiety
Time Frame: First study day and end of study (Day 1 and day 30)
|
Hospital Anxiety and Depression Scale.
Item scoring is 0 to 3. Response anchors vary across items.
Subscale range is 0-21.
Higher scores indicate more anxiety
|
First study day and end of study (Day 1 and day 30)
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|
Change in pain catastrophizing
Time Frame: First study day and end of study (Day 1 and day 30)
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Pain Catastrophizing Scale.
Item scoring is 0=not at all to 4=all the time.
Scale range is 0 to 52.
Higher scores indicate more catastrophizing
|
First study day and end of study (Day 1 and day 30)
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- GeneralAPP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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