A Skills-Based Program Delivered Via Secure Live Video to Patients With Acute Musculoskeletal Trauma

August 16, 2018 updated by: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

A Randomized Controlled Trial Testing a Skills-Based Program Called "A Toolkit for Optimal Recovery" Delivered Via Secure Live Video Compared to Standard Medical Care in Patients With Acute Musculoskeletal Injuries

The aims of this study are to test a manualized mind body skills-building program aimed at preventing the development of chronic pain and disability following acute musculoskeletal injury in at-risk patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a pilot randomized feasibility trial of the mind body program Toolkit for Optimal Recovery versus usual medical care. The Toolkit is delivered via secure live video to patients at risk for chronic pain, at 1-2 months after injury. The primary aim of this study is to determine the feasibility and acceptability of the program, randomization, procedures and outcome measures. Secondarily, we report means and standard deviation and explore change in quantitative outcomes in the Toolkit compared to usual care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of musculoskeletal injury in the past 1-2 months
  • 18 years of age or older
  • English fluency and literacy
  • PCS OR, PASS score above median split

Exclusion Criteria:

  • Major medical comorbidity expected to worsen in the next 6 months
  • Comorbid chronic pain condition
  • Antidepressant medication change in the past 6 months
  • Secondary gains such as litigations or workers compensation procedures
  • Diagnosis of psychosis, bipolar disorder or active substance dependence (by self report)
  • Unwilling or unable to use videoconferencing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Toolkit for Optimal Recovery after Injury
The Toolkit for Optimal Recovery after Injury (ToR) is a mind body skills based program delivered individually via secure live video. The format is a 4-week program with weekly meetings and a focus on teaching skills to optimize recovery and prevent chronic pain and disability.
Behavioral: The Toolkit for Optimal Recovery after Injury
The Toolkit for Optimal Recovery after Injury (ToR) is a skills based mind body program that was designed to prevent the development of chronic pain and disability following an acute musculoskeletal injury (e.g., fracture). The program has 4 sessions and it is delivered via live video. Patients learn myth about recovery after injury, false and real pain alarms, the fear avoidance model and how to prevent the disability spiral, mindfulness based exercises and activity pacing.
Other Names:
  • ToR
NO_INTERVENTION: Usual Care
The Usual Care (UC) group will continue with their current medical care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of recruitment
Time Frame: 0 Weeks
We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized
0 Weeks
Satisfaction with ToR
Time Frame: 4 weeks; 3 months
3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician.
4 weeks; 3 months
Acceptability
Time Frame: 4 weeks; 3 months
We will report number of patients who finished ToR and UC and completed post-test from those who started the study (were randomized); We will also report number of participants who provided 3 months follow up
4 weeks; 3 months
Feasibility of outcome measures
Time Frame: 0 weeks; 4 weeks; 3 months
We will report number of missing items and calculate reliability of outcome measures
0 weeks; 4 weeks; 3 months
Adherence to ToR
Time Frame: 4 weeks.
We will report number of participants who completed at least 3 out of 4 ToR sessions
4 weeks.
Adherence to homework
Time Frame: 4 weeks
determined by number of homework logs returned
4 weeks
Therapist adherence survey
Time Frame: 4 weeks
Items assessing whether the therapist taught each of the skills included in each of the 4 sessions
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Catastrophizing
Time Frame: 0 Weeks, 4 Weeks, 3 Months
Pain Catastrophizing Scale (PCS); items are summed to generate a total score; scores range from 0 to 52; higher scores indicate greater pain catastrophizing
0 Weeks, 4 Weeks, 3 Months
Pain Anxiety
Time Frame: 0 Weeks, 4 Weeks, 3 Months
Pain Anxiety Symptom Scale (PASS); items are summed to generate a total score; scores range from 0-100; higher sores indicate greater pain anxiety
0 Weeks, 4 Weeks, 3 Months
Depression
Time Frame: 0 Weeks, 4 Weeks, 3 Months
Center for Epidemiologic Studies Depression Scale (CESD); items are summed to generate a total score; scores range from 0 to 60; higher scores indicate greater depressive symptomatology
0 Weeks, 4 Weeks, 3 Months
Post Traumatic Stress Disorder
Time Frame: 0 Weeks, 4 Weeks, 3 Months
Post Traumatic Stress Disorder Checklist (PCL); items are summed to generate a total score; scores range from 17 to 85; higher scores indicate greater post traumatic stress
0 Weeks, 4 Weeks, 3 Months
Pain intensity
Time Frame: 0 Weeks, 4 Weeks, 3 Months
Numerical rating scale assessing pain form 0 to 10
0 Weeks, 4 Weeks, 3 Months
Physical Function
Time Frame: 0 Weeks, 4 Weeks, 3 Months
Short Musculoskeletal Function Assessment (SMFA); two scores are generated by summing items 1-34 for Function Index and 35-46 for Bothersome Index;
0 Weeks, 4 Weeks, 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014P001194

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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