Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG081299-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain.
The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time data capture, than remotely delivered exercise coaching alone.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Move and Snooze program | Experimental | This includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I). |
|
| Personalized exercise program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized exercise coaching | Behavioral | This is a 6-session personalized exercise coaching program (delivered over 8 weeks). All participants will complete six 30-minute scheduled online or phone sessions with a health coach as part of a manualized personalized exercise program (once per week for the first four sessions and then once every two weeks for the remaining two sessions). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period | This is a one question numerical rating scale in which participants select from 0 (no pain) -10 (worst pain imaginable) numerical rating scale 4 times a day over 7 days during each assessment period (baseline and 8-week follow-up). These four within-day ratings collected over seven days will be averaged for each participant to provide a single pain intensity rating for each assessment period. | Baseline, 8-week follow-up (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a questionnaire between baseline and 8-week follow-up (post-intervention) | There are 3 questions that participants answer and from no pain (1) - very severe (5). There is a total score of 15 with a higher score indicating higher pain intensity. | Baseline, 8-week (post-intervention) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jade Treder | Contact | 734-936-2844 | trederj@med.umich.edu | |
| Kristin Pickup | Contact | 734-764-4072 | knpicku@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Whibley, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
After the study is completed, the de-identified, archived data will be transmitted to and stored at the Inter-university Consortium for Political and Social Research data repository.
Final submission and release of the study data will occur approximately 8 and 12 months following the end of fieldwork, respectively, and within the award period. Study data deposited in the Inter-university Consortium for Political and Social Research data repository will be available to the research community in perpetuity.
Public use and restricted access study data and associated documentation will be made available to the research community free of charge through the Inter-university Consortium for Political and Social Research data repository.
Not provided
Enrolled participants will be randomized in blocks, stratified by biological sex, age, and baseline pain intensity (per protocol)
Not provided
Not provided
Not provided
Not provided
|
| Cognitive behavioral therapy for Insomnia | Behavioral | This is a 6-week course of automated, digitally delivered cognitive behavioral therapy for insomnia delivered by the online program Sleepio. The weekly sessions will last approximately 15-20 minutes. Session content comprises evidence-based cognitive and behavioral techniques including Stimulus Control Therapy and Sleep Restriction Therapy, sleep hygiene education, and relaxation exercises. |
|
| Change in the PROMIS Pain Interference 8a questionnaire between baseline and 8-week follow-up (post-intervention) | There are 8 questions regarding the extent to which pain has interfered with activities over the past 7 days, ranging from not at all (1) - Very much (5). Total scores range from 8 to 40, with a higher score representing higher interference due to pain. | Baseline, 8-week (post-intervention) |
| Change in the PROMIS Physical Function questionnaire between baseline and 8-week follow-up (post-intervention) | There are 4 questions regarding function that participants answer and from without any difficulty (5) - unable to do (1). And 4 questions for that participants select from not at all (5) to cannot do (1). There is a total score of 40 with a higher score indicating greater physical function. | Baseline, 8-week (post-intervention) |
| Change in the Quality of Life subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) between baseline and 8-week follow-up (post-intervention) | The KOOS quality of life subscale includes 4 questions. The Score subscale is scored using a Likert scale with five possible answers, ranging from 0 (no problems) to 4 (extreme problems). The quality of life subscale score is then normalized to a 0-100 scale, with higher scores equaling better status. 0 represents extreme knee problems and 100 represents no knee problems. | Baseline, 8-week (post-intervention) |
| Patient Global Impression of Change at 8-week follow-up (post-intervention) | This is a one question survey that participants will select from very much improved (1) -very much worse (7) since the start of the study and overall status. A lower number indicates better outcome. | 8-week (post-intervention) |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided