Acceptance and Commitment Therapy Delivered by Automated Software Messaging

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-05

Study Completion Date

2020-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Automated Text Messaging Services

NCT05621265

Sleep Physical Therapy

COMPLETED NA

Cooperative Pain Education and Self-management

NCT02724930

Chronic Low Back Pain

COMPLETED NA

The Effect of Smartphone-Based Recording Offer on Patient Satisfaction in Orthopedic Care

NCT06998212

Patient Satisfaction

NOT_YET_RECRUITING NA

Home Telerehabilitation for Deconditioned Older Adults

NCT00386256

Osteoarthritis

COMPLETED NA

Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors

NCT04663945

Covid-19 Deconditioning

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Osteoarthritis Knee Osteoarthritis Mental Stress Coronavirus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment Two study groups. The intervention group and the control group that does not receive the intervention

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Software Messaging

Intervention Type BEHAVIORAL

Acceptance and Commitment Therapy Delivered via an Automated Mobile Messaging Robot Mobile messages utilizing the principles of Acceptance and Commitment therapy. These messages were developed in collaboration with a pain psychologist who specializes in treating chronic pain with Acceptance and Commitment therapy. Subjects received twice-daily messages for two weeks following their orthopaedic procedure.

Control

Subjects randomizing into this arm did not receive the text message study intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Software Messaging

Acceptance and Commitment Therapy Delivered via an Automated Mobile Messaging Robot Mobile messages utilizing the principles of Acceptance and Commitment therapy. These messages were developed in collaboration with a pain psychologist who specializes in treating chronic pain with Acceptance and Commitment therapy. Subjects received twice-daily messages for two weeks following their orthopaedic procedure.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.