Effect of the PainCoach App on Pain and Opiate Use After Total Knee Replacement

NCT ID: NCT03961152

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-15

Study Completion Date

2017-06-08

Brief Summary

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Less is known about pain and opiate use at home directly after total knee replacement (TKR). Regarding side effects, low opiate use is desired. An e-health application, PainCoach app, was developed to guide patients in pain control and opiate use.

The aim of this study was to investigate the effect of the PainCoach app on pain and opiate use in TKR patients in the first two weeks at home after surgery. The hypothesis was that the use of this app would decrease pain and opiate use.

Detailed Description

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Conditions

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Total Knee Replacement Pain Opioid Use E-health App

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomised to the PainCoach-app group or control group. Both groups received usual care. In the PainCoach-app group, in addition to receiving the aforementioned usual care, patients could use the PainCoach app whenever they wanted. In response to the patient's input of the pain experienced, the app gave advice on pain medication use, exercises/rest and when to call the clinic. This advice was the same as patients also received during usual care.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PainCoach-app group

In the PainCoach-app group, in addition to receiving the aforementioned usual care, the PainCoach app was downloaded on each patient's smartphone or tablet. Patients could use this app whenever they wanted until day 14 after surgery. They were not subjected to any different treatment compared to the control group, i.e. advice on pain management was delivered in an extra and different way, but the pain medication itself was exactly the same for both groups.

Group Type EXPERIMENTAL

PainCoach app

Intervention Type BEHAVIORAL

In response to the patient's input of the pain experienced (no pain, bearable pain, unbearable pain, or untenable pain), the app gave advice on pain medication use, exercises/rest and when to call the clinic from day 1 until day 14 after surgery.

Control group

The control group received usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PainCoach app

In response to the patient's input of the pain experienced (no pain, bearable pain, unbearable pain, or untenable pain), the app gave advice on pain medication use, exercises/rest and when to call the clinic from day 1 until day 14 after surgery.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Planned for primary TKR

Exclusion Criteria

* No possession of a smartphone or tablet
* Contra-indication to any of the pain medication used in the study
* No email address
* No internet at home
* No thorough command of the Dutch language
* Suffering from memory disorders
* Surgery under general anaesthesia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Anna Ziekenhuis, Geldrop, Netherlands

OTHER

Sponsor Role collaborator

Kliniek ViaSana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J.M. Brinkman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kliniek ViaSana

Locations

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Kliniek ViaSana

Mill, , Netherlands

Site Status

Countries

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Netherlands

References

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Pronk Y, Peters MCWM, Sheombar A, Brinkman JM. Effectiveness of a Mobile eHealth App in Guiding Patients in Pain Control and Opiate Use After Total Knee Replacement: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 13;8(3):e16415. doi: 10.2196/16415.

Reference Type DERIVED
PMID: 32167483 (View on PubMed)

Other Identifiers

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PainCoach app study

Identifier Type: -

Identifier Source: org_study_id

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