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出境医 / 临床实验 / Effect of the PainCoach App on Pain and Opiate Use After Total Knee Replacement
Effect of the PainCoach App on Pain and Opiate Use After Total Knee Replacement
Study Description
Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Total Knee Replacement Pain Opioid Use E-health App | Behavioral: PainCoach app | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 97 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 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. |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Effect of the PainCoach App on Pain and Opiate Use in the First Two Weeks After Total Knee Replacement: Randomised Controlled Trial |
| Actual Study Start Date : | January 15, 2016 |
| Actual Primary Completion Date : | July 6, 2016 |
| Actual Study Completion Date : | June 8, 2017 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Behavioral: 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.
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No Intervention: Control group
The control group received usual care.
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Outcome Measures
Primary Outcome Measures :
- Change in pain at rest in the first two weeks at home after TKR [ Time Frame: 14 measurement points: daily from day 1 to 14 after surgery ]Pain at rest was daily measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
- Change in pain during activity in the first two weeks at home after TKR [ Time Frame: 14 measurement points: daily from day 1 to 14 after surgery ]Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
- Change in pain at night in the first two weeks at home after TKR [ Time Frame: 14 measurement points: daily from day 1 to 14 after surgery ]Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
- Change in opiate use in the first two weeks at home after TKR [ Time Frame: 14 measurement points: daily from day 1 to 14 after surgery ]Oxycodon (5 mg per tablet) use was recorded in quantities per 24 hours
Secondary Outcome Measures :
- Pain at rest [ Time Frame: 1 month after surgery ]Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
- Pain during activity [ Time Frame: 1 month after surgery ]Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
- Pain at night [ Time Frame: 1 month after surgery ]Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
- Change in other pain medication use in the first two weeks at home after TKR [ Time Frame: 14 measurement points: daily from day 1 to 14 after surgery ]i.e. NSAID (Diclofenac), acetaminophen and/or Gabapentin were recorded in quantities per 24 hours
- Change in pain acceptance at rest, during activity and at night in the first two weeks at home after TKR [ Time Frame: 14 measurement points: daily from day 1 to 14, and at 1 month after surgery ]Measured with a happy smiley (acceptable pain) and a sad smiley (unacceptable pain)
- Change in experiences with the executed recommended physiotherapy exercises in the first two weeks at home after TKR [ Time Frame: 14 measurement points: daily from day 1 to 14 after surgery ]Measured on a 3-item scale; did too much, exactly enough, or could have done more exercises
- Function [ Time Frame: 1 month after surgery ]Measured with the Knee injury and Osteoarthritis Outcome Score - Physical Function Short-form (KOOS-PS) with a total score from 0 (no difficulty) to 100 (extreme difficulty)
- Function and pain [ Time Frame: 1 month after surgery ]Measured with the Oxford Knee Score (OKS) with a total score from 0 (most severe symptoms) to 48 (least severe symptoms)
- Quality of life [ Time Frame: 1 month after surgery ]Measured with the EuroQol-5D 3 level version (EQ-5D-3L) consisting of two scores: EQ Visual Analogue Scale (EQ VAS) score from 0 (worst imaginable health state) to 100 (best imaginable health state), and EQ-5D descriptive system (EQ-5D index).
- PainCoach app's perceived effectiveness [ Time Frame: Day 14 after surgery ]Usability, added value, and likelihood of being recommended to others was recorded on a 5-item scale ranging from totally agree to totally disagree
- Active PainCoach app use [ Time Frame: From day 1 to 14 after surgery ]Measured with recording the actual amount of app use and defining active use as at least 12 times in total
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Locations
| Netherlands | |
| Kliniek ViaSana | |
| Mill, Netherlands | |
Sponsors and Collaborators
Kliniek ViaSana
St. Anna Ziekenhuis, Geldrop, Netherlands
Investigators
| Principal Investigator: | J.M. Brinkman, MD, PhD | Kliniek ViaSana |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 14, 2019 | ||||
| First Posted Date ICMJE | May 23, 2019 | ||||
| Last Update Posted Date | May 23, 2019 | ||||
| Actual Study Start Date ICMJE | January 15, 2016 | ||||
| Actual Primary Completion Date | July 6, 2016 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of the PainCoach App on Pain and Opiate Use After Total Knee Replacement | ||||
| Official Title ICMJE | Effect of the PainCoach App on Pain and Opiate Use in the First Two Weeks After Total Knee Replacement: Randomised Controlled Trial | ||||
| Brief Summary |
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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 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. Masking: Single (Outcomes Assessor)Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: 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.
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| Study Arms ICMJE |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
97 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | June 8, 2017 | ||||
| Actual Primary Completion Date | July 6, 2016 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Netherlands | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03961152 | ||||
| Other Study ID Numbers ICMJE | PainCoach app study | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Kliniek ViaSana | ||||
| Study Sponsor ICMJE | Kliniek ViaSana | ||||
| Collaborators ICMJE | St. Anna Ziekenhuis, Geldrop, Netherlands | ||||
| Investigators ICMJE |
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| PRS Account | Kliniek ViaSana | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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