Acceptance and Commitment Therapy Delivered by Automated Software Messaging

Not Applicable

Completed

• Conditions: Mental Stress; Knee Osteoarthritis; Coronavirus; Hip Osteoarthritis
• Interventions: Behavioral: Software Messaging

• Registration Number: NCT04329897
• Lead Sponsor: University of Iowa

Brief Summary

This study aims to 1) observe the course of pain, 2) mental status, and 3) possible effect of a behavioral intervention delivered via an automated mobile phone messaging robot in patients were indicated and/or scheduled to undergo joint replacement but have been cancelled or delayed due to the COVID-19 crisis.

Detailed Description

Adult patients presenting to a University Hospital and found to have hip and knee osteoarthritis that had failed conservative management were subsequently indicated for primary hip or knee replacement (arthroplasty). Patients who subsequently had their surgery delayed or cancelled due to the COVID-19 pandemic were eligible for this study. Eligible patients consenting to the study will be assigned a unique study identification number (ID). A master database linking patient ID to patient name and medical record number will be housed on a password protected and encrypted departmental server location, which only research personnel can access.

Participants will complete a basic demographics survey and preoperative/ baseline patient reported outcome surveys at enrollment, including the Patient-reported outcomes measurement information system (PROMIS) Pain Intensity 1A short form, PROMIS Pain Intensity 3A short form, PROMIS Pain Interference 8A short form, and PROMIS 8A Emotional Distress-Anxiety 8A short forms. Following completion of these surveys, subjects will be randomized in a 1:1 ratio using a random number generator into one of two study groups. The intervention group will receive mobile messages communicating the behavior intervention. The control group will not receive the intervention. Subjects will not be blinded to their study group. Participants randomized to the intervention group were subsequently enrolled into the automated mobile messaging protocol and received a confirmation message welcoming them to the study, which was reviewed with them by the research assistant. Subjects were instructed that they were only required to read all messages, no responses were required.

A single instance of follow-up will take place on Day 14 of the study. This will occur over the phone with a research team member. Subjects will fill out a second set of the patient reported outcome surveys completed at enrollment. Collection of these followup items marks the end of the subject's participation in the study. No data collection is planned following the two week study period. The study hypothesis is that subjects receiving the behavior intervention delivered via an automated mobile messaging robot would demonstrate better patient reported outcome survey scores than controls at follow-up.

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-04-01
• Study Start: 2020-04-05
• Primary Completion: 2020-05-15
• Study Completion: 2020-06-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Any patient who had been indicated for primary joint replacement but subsequently experienced a delay or cancellation in their surgical date due to the COVID-19 pandemic.

Exclusion Criteria

• Patients undergoing revision joint replacement
• Patients who do not own a mobile phone or do not utilize text messaging as a form of communication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Software Messaging	Software Messaging	Acceptance and Commitment Therapy Subjects randomizing into this arm received the study intervention that consisted of twice-daily, AM and PM, text messages starting on postoperative day one and ending on postoperative day fourteen. Subjects were only required to read these messages, which utilized the principles of Acceptance and Commitment therapy

Primary Outcome Measures

Name	Time	Method
Change in reported pain intensity score (PROMIS Pain Intensity 3A) Patient-reported outcomes measurement information system Pain Intensity (PROMIS) 3A short form scores collected from all participating subjects.	Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.	PROMIS Pain Intensity 3A short form is a 3 question survey measuring an individual's pain over the past 7 days. It utilizes a scale of 1 (no pain) to 5 (very severe pain) for all questions. The scores for the 3 questions are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 30.7 to 71.8 for the PROMIS Pain Intensity 3A instrument. Higher t-score values represent worse pain outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net
Change in reported emotional distress (anxiety) score. Patient-reported outcomes measurement information system (PROMIS) Emotional Distress-Anxiety 8A short form scores collected from all participating subjects.	Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.	The PROMIS Emotional Distress-Anxiety 8A short form is an 8 statement survey that measures how much emotional distress, specifically due to anxiety, a respondent has experienced over the past 7 days. It utilizes a scale of 1 (never) to 5 (always) for all the statements. The scores for all 8 statements are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 37.1 to 83.1 for the PROMIS Emotional Distress-Anxiety 8A instrument. Higher t-score values represent worse anxiety caused emotional distress outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net
Change in reported pain intensity score (PROMIS Pain Intensity 1A) Patient-reported outcomes measurement information system Pain Intensity (PROMIS) 1A short form scores collected from all participating subjects.	Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.	PROMIS Pain Intensity 1A short form is a 1 question survey measuring an individual's average pain over the past 7 days. It utilizes a scale of 0 (no pain) to 10 (worst imaginable pain). Higher values represent worse pain outcomes.; More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net
Change in reported pain interference score Patient-reported outcomes measurement information system (PROMIS) Pain Interference 8A short form scores collected from all participating subjects.	Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.	The PROMIS Pain Interference 8A short form is an 8 question survey that measures how much pain has interfered in the respondent's life over the past 7 days. It utilizes a scale of 1 (not at all) to 5 (very much) for all questions.; The scores for all 8 questions are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 40.7 to 77.0 for the PROMIS Pain Interference 8A instrument. Higher t-score values represent worse pain interference outcomes.; More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States