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

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Temporomandibular Joint Dysfunction Syndrome
• Intervention: Behavioral: PACT Experimental Arm
• Enrollment: 80

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Traditional Self-Care Control Arm	PACT Experimental Arm
Arm/Group Description	Traditional self-care focuses on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants in the traditional arm may also be receiving usual care from their dentist such as a splint or anti-inflammatory medications. They will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).	Participants enrolled in the experimental arm are prompted to complete a self-management program, Personalized Activated Care and Training (PACT), 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 designed to improve TMD pain. Participants also complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). These participants are also supported by a health coach.
Period Title: Overall Study
Started	41	39
Completed	39	36
Not Completed	2	3

Baseline Characteristics

Arm/Group Title		Traditional Self-Care Control Arm	PACT Experimental Arm	Total
Arm/Group Description		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). .	PACT Experimental Arm: The study employs 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.	Total of all reporting groups
Overall Number of Baseline Participants		41	39	80
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	41 participants	39 participants	80 participants
		49 (15.1)	46 (17.1)	47.5 (16.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	39 participants	80 participants
	Female	35 85.4%	34 87.2%	69 86.3%
	Male	6 14.6%	5 12.8%	11 13.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	39 participants	80 participants
	Hispanic or Latino	2 4.9%	1 2.6%	3 3.8%
	Not Hispanic or Latino	38 92.7%	38 97.4%	76 95.0%
	Unknown or Not Reported	1 2.4%	0 0.0%	1 1.3%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	39 participants	80 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	1 2.4%	0 0.0%	1 1.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 4.9%	3 7.7%	5 6.3%
	White	36 87.8%	34 87.2%	70 87.5%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	2 4.9%	2 5.1%	4 5.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	41 participants	39 participants	80 participants
		41	39	80
Graded Chronic Pain Severity [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	41 participants	39 participants	80 participants
		50 (15)	50 (17.6)	50 (16)
		[1] Measure Description: Pain Intensity is a O-100 score derived from questions 1-3: Mean (Pain Right Now, Worst Pain, Average Pain) x 10; Item Scale is from 0=No pain to 10=Pain as bad as it could be
Graded Chronic Pain interference [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	41 participants	39 participants	80 participants
		26.6 (23.7)	23 (21.3)	24.9 (22.5)
		[1] Measure Description: Graded Chronic Pain Interference subscale: Interference Score is a O-100 score derived from 3 questions: Mean (Daily Activities, Social Activities, Work Activities) x 10; Scale 0=no interference up to 10=unable to carry on activities
Jaw Functioning [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	41 participants	39 participants	80 participants
		24.5 (18.9)	19.4 (14)	22 (16.8)
		[1] Measure Description: Level of limitation during the last 30 days. Scale 0-10 of drink, Soft food, Swallow, Talk, Smile, Chew, Yawn, Hard food. JAW FUNCTIONING 8 items R:0-80; Item scale: 0 = No limitation up to 10=Severe limitation

Outcome Measures

1. Primary Outcome

Title	Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program
Description	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)
Time Frame	Change from baseline to 16 weeks post intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Traditional Self-Care Control Arm	PACT Experimental Arm
Arm/Group Description:	Traditional self-care focuses on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants in the traditional arm may also be receiving usual care from their dentist such as a splint or anti-inflammatory medications. They will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).	Participants enrolled in the experimental arm are prompted to complete a self-management program, Personalized Activated Care and Training (PACT), 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 designed to improve TMD pain. Participants also complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). These participants are also supported by a health coach.
Overall Number of Participants Analyzed	39	36
Mean (Standard Deviation); Unit of Measure: units on a scale
	-12 (16.8)	-19 (16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Traditional Self-Care Control Arm, PACT Experimental Arm
	Comments	Pilot study, no power analysis applicable; no statistical test
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Assessing Change in Jaw Functioning
Description	Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)
Time Frame	Change from baseline to 16 weeks post intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Traditional Self-Care Control Arm	PACT Experimental Arm
Arm/Group Description:	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). .	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.
Overall Number of Participants Analyzed	39	36
Mean (Standard Deviation); Unit of Measure: units on a scale
	-7.9 (14.9)	-6.9 (19.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Traditional Self-Care Control Arm, PACT Experimental Arm
	Comments	Pilot study; no statistical test run
	Type of Statistical Test	Other
	Comments	pilot study; no statistical test performed
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Graded Chronic Pain Interference
Description	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.
Time Frame	Change from baseline to 16 weeks post intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Traditional Self-Care Control Arm	PACT Experimental Arm
Arm/Group Description:	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). .	PACT Experimental Arm: The study employs 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.
Overall Number of Participants Analyzed	39	36
Mean (Standard Deviation); Unit of Measure: units on a scale
	-5.8 (20.7)	-11 (17.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Traditional Self-Care Control Arm, PACT Experimental Arm
	Comments	Pilot study; no statistical test for significance run
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.2
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	through study completion; an average of 16 weeks.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Traditional Self-Care Control Arm	PACT Experimental Arm
Arm/Group Description	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). .	PACT intervention employs 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.
All-Cause Mortality
	Traditional Self-Care Control Arm	PACT Experimental Arm
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/41 (0.00%)	0/39 (0.00%)
Serious Adverse Events
	Traditional Self-Care Control Arm	PACT Experimental Arm
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/41 (0.00%)	0/39 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Traditional Self-Care Control Arm	PACT Experimental Arm
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/41 (0.00%)	0/39 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: James Fricton, DDS, Senior Research Investigator
• Organization: HealthPartners Institute
• Phone: 6126191678
• EMail: james.r.fricton@healthpartners.com

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT03036215
• Other Study ID Numbers: 5U01DE025609-02 ( U.S. NIH Grant/Contract )
• First Submitted: January 18, 2017
• First Posted: January 30, 2017
• Results First Submitted: February 20, 2018
• Results First Posted: June 15, 2018
• Last Update Posted: June 15, 2018