Acceptance and Commitment Therapy Delivered by Automated Software Messaging
Purpose
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.
Conditions
- Hip Osteoarthritis
- Knee Osteoarthritis
- Mental Stress
- Coronavirus
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Parallel Assignment Two study groups. The intervention group and the control group that does not receive the intervention
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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 |
|
|
No Intervention Control |
Subjects randomizing into this arm did not receive the text message study intervention. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04329897
- Status
- Completed
- Sponsor
- University of Iowa
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.