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The primary objective of this project is to examine effectiveness of a tailored pacing intervention on fatigue, pain, and physical function compared to general pacing intervention and usual care groups. A secondary objective is to evaluate the natural history of symptoms and physical disability over time among people with knee and hip osteoarthritis.
In the United States, osteoarthritis is a growing public health issue and a leading cause of disability among older adults. Almost 50% of users of the Veterans Affairs (VA) system present with osteoarthritis. Veterans are a particularly important group to target for symptom management interventions as they are twice as likely as non-veterans to report chronic joint symptoms and activity limitations. There are few evidence-based symptom management interventions offered by health care professionals, such as occupational and physical therapists, at the time when people are seeking treatment for their symptoms. The proposed activity pacing intervention is individually-tailored to a person's symptom and activity patterns. This tailoring provides a personally-relevant and focused intervention that may help people adopt this strategy into their daily lives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Tailored activity pacing |
|
| Arm 2 | Experimental | General activity pacing and symptom management (Occupational therapy) |
|
| Arm 3 | No Intervention | Usual care group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Activity Pacing | Behavioral | Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue- Brief Fatigue Inventory (BFI) | This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue. | Baseline |
| Fatigue-BFI | This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue. | 10 weeks post-baseline |
| Fatigue-BFI | This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue. | 6 months post-baseline |
| Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain. | Baseline |
| Pain- WOMAC | This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain. | 10 weeks post-baseline |
| Pain- WOMAC | This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain. | 6 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function- Six Minute Walk | Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes | Baseline |
| Physical Function- Six Minute Walk | This is the distance in feet that people walk over 6 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan L Murphy, ScD OTR | VA Ann Arbor Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48113 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27207435 | Derived | Murphy SL, Schepens Niemiec S, Lyden AK, Kratz AL. Pain, Fatigue, and Physical Activity in Osteoarthritis: The Moderating Effects of Pain- and Fatigue-Related Activity Interference. Arch Phys Med Rehabil. 2016 Sep;97(9 Suppl):S201-9. doi: 10.1016/j.apmr.2015.05.025. Epub 2016 May 17. | |
| 21810253 | Derived | Murphy SL, Lyden AK, Clary M, Geisser ME, Yung RL, Clauw DJ, Williams DA. Activity pacing for osteoarthritis symptom management: study design and methodology of a randomized trial testing a tailored clinical approach using accelerometers for veterans and non-veterans. BMC Musculoskelet Disord. 2011 Aug 2;12:177. doi: 10.1186/1471-2474-12-177. |
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Potential participants were recruited through fliers and advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Activity Pacing | Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant. |
| FG001 | General Activity Pacing | General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms |
| FG002 | Usual Care Group | Participants receiving usual care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Tailored activity pacing Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant. |
| BG001 | Arm 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fatigue- Brief Fatigue Inventory (BFI) | This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
Data were collected from baseline through completion of Time 3 outcome measures at 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Tailored activity pacing Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| x-ray mistakes | Musculoskeletal and connective tissue disorders | Systematic Assessment | most other reportable events occurred because of x-ray errors. One subject had their hips x-rayed instead of knees. Other subjects had incomplete views of their knees on xray |
Although overall effects were not found by group over time, additional data analyses will be conducted to determine if there were positive effects for specific subgroups of people.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Health Science Specialist | Veterans Affairs--Ann Arbor Health Care System | 734-936-2123 | sumurphy@umich.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| General Activity Pacing | Behavioral | Therapeutic intervention using generalized pacing instruction to manage symptoms |
|
| 10 weeks post-baseline |
| Physical Function- Six Minute Walk | This is the distance people walk in feet over 6 minutes | 6 months post baseline |
| started new treatment |
|
| Unable to follow Actiwatch instructions |
|
General activity pacing and symptom management
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
| BG002 | Arm 3 | Usual care group |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | All participants were recruited in the Southeastern Michigan Area | Number | participants |
|
| OG002 | Usual Care Group | Participants receiving usual care |
|
|
| Primary | Fatigue-BFI | This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue. | Sample numbers may differ due to missing data | Posted | Mean | Standard Deviation | units on a scale | 10 weeks post-baseline |
|
|
|
| Primary | Fatigue-BFI | This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue. | Sample numbers may vary due to missing data | Posted | Mean | Standard Deviation | units on a scale | 6 months post-baseline |
|
|
|
|
| Primary | Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Pain- WOMAC | This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain. | Sample numbers may differ due to missing data | Posted | Mean | Standard Deviation | units on a scale | 10 weeks post-baseline |
|
|
|
| Primary | Pain- WOMAC | This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain. | Numbers may vary due to missing data | Posted | Mean | Standard Deviation | units on a scale | 6 months post baseline |
|
|
|
|
| Secondary | Physical Function- Six Minute Walk | Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes | Numbers may vary due to missing data | Posted | Mean | Standard Deviation | feet | Baseline |
|
|
|
| Secondary | Physical Function- Six Minute Walk | This is the distance in feet that people walk over 6 minutes. | Numbers may differ due to missing data | Posted | Mean | Standard Deviation | feet | 10 weeks post-baseline |
|
|
|
| Secondary | Physical Function- Six Minute Walk | This is the distance people walk in feet over 6 minutes | Numbers may differ due to missing data | Posted | Mean | Standard Deviation | feet | 6 months post baseline |
|
|
|
|
| 0 |
| 66 |
| 3 |
| 66 |
| EG001 | Arm 2 | General activity pacing and symptom management General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms | 0 | 66 | 3 | 66 |
| EG002 | Arm 3 | Usual care group | 0 | 63 | 1 | 63 |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |