Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology (TMDPACT)
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|ClinicalTrials.gov Identifier: NCT03036215|
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Joint Dysfunction Syndrome||Behavioral: PACT Experimental Arm||Not Applicable|
The primary study objectives of the PACT study are two-fold:
- 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||80 participants|
|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|
|Official Title:||Tailored Self-Management of TMD Pain Using Health Information Technology|
|Actual Study Start Date :||May 8, 2017|
|Actual Primary Completion Date :||November 9, 2017|
|Actual Study Completion Date :||November 9, 2017|
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).
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.
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036215
|United States, Minnesota|
|Saint Paul, Minnesota, United States, 55108|
|Principal Investigator:||James R. Fricton, DDS||HealthPartners Institute|
|Principal Investigator:||Robin R. Whitebird, PhD, MSW||University of St Thomas , School of Social Work|