Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology (TMDPACT)

• ClinicalTrials.gov Identifier: NCT03036215
• Recruitment Status: Completed
• First Posted: January 30, 2017
• Results First Posted: June 15, 2018
• Last Update Posted: June 15, 2018
• Sponsor: HealthPartners Institute
• Information provided by (Responsible Party): HealthPartners Institute

Tracking Information

• First Submitted Date: January 18, 2017
• First Posted Date: January 30, 2017
• Results First Submitted Date: February 20, 2018
• Results First Posted Date: June 15, 2018
• Last Update Posted Date: June 15, 2018
• Actual Study Start Date: May 8, 2017
• Actual Primary Completion Date: November 9, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 16, 2018)

• Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program [ Time Frame: Change from baseline to 16 weeks post intervention ]
  Measure: Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported current, worst, and average pain. 3 items: Scale 0-100 (100 most severe)
• Assessing Change in Jaw Functioning [ Time Frame: Change from baseline to 16 weeks post intervention ]
  Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)

Original Primary Outcome Measures (submitted: January 26, 2017)

• Assessing change in pain severity Evaluation feasibility of the PACT Program [ Time Frame: Change from baseline to 16 week s post intervention ]
  Measure: Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported current, worst, and average pain.99-100 (alpha >0.74)
• Assessing change in jaw functioning [ Time Frame: Change from baseline to 16 weeks post intervention ]
  Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain.40 (alpha =0.81)

Current Secondary Outcome Measures (submitted: May 16, 2018)

Graded Chronic Pain Interference [ Time Frame: Change from baseline to 16 weeks post intervention ]

Assessment of graded Chronic Pain Interference - Scale (0-100); 0 = lowest pain interference 100 = highest pain interference. If findings in negative values = improvement; positive values = worsening condition.

Original Secondary Outcome Measures (submitted: January 26, 2017)

• Pain Interference [ Time Frame: at baseline, at 8 weeks and 16 weeks post intervention ]
  Graded Chronic Pain Scale
• Pain timing [ Time Frame: at baseline, 0-8 week intervention, at 8 weeks and 16 weeks post intervention ]
  Symptom Severity Index

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology
• Official Title: Tailored Self-Management of TMD Pain Using Health Information Technology
• Brief Summary: The purpose of this pilot project is to determine the feasibility and acceptability of proposed methods for a subsequent clinical trial of a tailored self-management program (PACT) designed to decrease pain in participants with temporomandibular disorders (TMD). The PACT program is a personalized program of exercise and behavioral changes implemented through a web-based program supported by a health coach. For this feasibility and acceptability study, 80 adults with TMD pain will be randomized either to the PACT program or to traditional self-care.

Detailed Description

The primary study objectives of the PACT study are two-fold:

1. Evaluate the feasibility of methods to conduct a full-scale multi-site randomized clinical trial comparing PACT self-management with traditional self-care for TMD. The study will also evaluate strategies to: identify, recruit, consent, and enroll eligible subjects into both groups meeting target goal; evaluate adherence to intervention and identification of barriers; evaluate adherence to outcomes assessment, and evaluate the on-line web-site functionality and acceptability.
2. To demonstrate ability to accurately capture outcome measures to be used in the multi-site study.

Primary study objective: Recruitment is measured through achievement of target sample, number of patients identified that meet eligibility criteria, and number (%) of subjects consenting compared with total contacted.

Intervention adherence is measured by: number of participants enrolled in both groups, number of participants accessing on-line materials, completion of practice logs, and identification of self-reported barriers of participation in self-care. Outcome adherence is measured by the number of participants who complete the baseline assessment, complete the two and four month follow-up assessments, complete the program evaluation, and complete qualitative post-study interview. Website acceptability is measure by identification of problems and barriers during use and quality and ease of use at the post-intervention evaluation.

Second objective: Efficacy of the program is measured by self-reported outcome assessments. The primary outcomes include TMD symptoms, jaw functioning, and emotional functioning. Secondary outcomes measures include symptom severity with the temporal aspects of pain, pain interference, and patient ratings of improvement. Additional information on mediators and modifiers will also be gathered to help inform the how and why the intervention has an effect. Mediators will be measured to identify factors that help explain why PACT may have an effect including self-efficacy, patient activation, exercise level, sleep quality, and social support. Contextual process factors to identify in whom the intervention does and does not work include disability status, catastrophizing, depression, repetitive strain from oral habits, and perceived stress.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The pilot study design is a 2-arm randomized clinical trial to test the methods that will be used in a future proposal for a full-scale multi-site clinical trial. The two aims include: 1) evaluate the feasibility of methods to conduct a full-scale multi-site randomized clinical trial comparing the PACT self-management with usual self-care for TMD and, 2) estimate the parameters needed to plan for a larger multi-site trial including the effect size and standard deviation for primary outcomes of pain and function. A traditional self-care control arm is added to determine the acceptability of randomization and the feasibility of collecting baseline and follow-up data from a traditional care control arm for the full-scale study.

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: Temporomandibular Joint Dysfunction Syndrome

Intervention

Behavioral: PACT Experimental Arm

The study will employ a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.

Study Arms

• No Intervention: Traditional Self-Care Control Arm
  Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .
• Experimental: PACT Experimental Arm
  If selected for the PACT care arm, participant will be prompted to complete a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. Participant will also participate in usual care from the dentist such as a splint or anti- inflammatory medications.Participant will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).
  Intervention: Behavioral: PACT Experimental Arm

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2017): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 9, 2017
• Actual Primary Completion Date: November 9, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Age 18 or older
  • Able and willing to access the internet on a regular basis
  • Able to read and speak English

  • Be willing to comply with all study procedures:

    1. Randomly assigned to either arm of the study
    2. Be available for the duration of the study
    3. Complete study data collection forms
    4. Reachable by phone and able to participate in weekly phone coaching calls if randomized to the PACT arm

  • Have a diagnosis of TMD pain using a self-report screener. These questions include;

    1. In the last 30 days, which of the following best describes any pain in your jaw or temple area on either side?
    2. In the last 30 days, have you had pain or stiffness in your jaw on awakening?
    3. In the last 30 days, did the following activities change any pain (that is, make it better or make it worse) in your jaw or temple area on either side? Chewing hard or tough food, Opening your mouth or moving your jaw forward or to the side, Jaw habits such as holding teeth together, clenching/grinding, or chewing gum, or other jaw activities such as talking, kissing, or yawning
  • Frequency of TMD pain more than once a week with pain in the past 6 months
  • Electronically sign an informed consent form

Exclusion Criteria:

• An individual who meets any of the following criteria will be excluded from participation in this study:

  • Currently participating in any other TMD and temporomandibular joint (TMJ) related studies
  • Major disk disorder that requires opioids or surgery for TMD pain
  • Serious medical condition that might interfere with or prohibit participation in an online program or pregnancy
  • Treatment for a mental health disorder or substance abuse in the past six months

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03036215
• Other Study ID Numbers: 5U01DE025609-02( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: HealthPartners Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: HealthPartners Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: James R. Fricton, DDS; HealthPartners Institute
• Principal Investigator: Robin R. Whitebird, PhD, MSW; University of St Thomas , School of Social Work

• PRS Account: HealthPartners Institute
• Verification Date: January 2017