Clinical trial NCT03036215: Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology
Official title: Tailored Self-Management of TMD Pain Using Health Information Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program
timeFrame: Change from baseline to 16 weeks post intervention
measure: Assessing Change in Jaw Functioning
timeFrame: Change from baseline to 16 weeks post intervention
Secondary outcomes:
measure: Graded Chronic Pain Interference
timeFrame: Change from baseline to 16 weeks post intervention
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Clinic
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: James R. Fricton, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of St Thomas , School of Social Work
name: Robin R. Whitebird, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: