Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis (AIM)
This study is currently recruiting participants.
Verified March 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01192516
First received: August 25, 2010
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoarthritis Pain |
Behavioral: Tailored Activity Pacing Behavioral: General Activity Pacing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Fatigue- Brief Fatigue Inventory (BFI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fatigue-BFI [ Time Frame: 10 weeks post-baseline ] [ Designated as safety issue: No ]
- Fatigue-BFI [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]
- Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Pain- WOMAC [ Time Frame: 10 weeks post-baseline ] [ Designated as safety issue: No ]
- Pain- WOMAC [ Time Frame: 6 months post baseline ] [ Designated as safety issue: No ]
- Physical Function- Six minute walk [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Physical Function- Six minute walk [ Time Frame: 10 weeks post-baseline ] [ Designated as safety issue: No ]
- Physical Function- Six Minute Walk [ Time Frame: 6 months post baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 172 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Tailored activity pacing
|
Behavioral: Tailored Activity Pacing
Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
|
|
Experimental: Arm 2
General activity pacing and symptom management (Occupational therapy)
|
Behavioral: General Activity Pacing
Therapeutic intervention using generalized pacing instruction to manage symptoms
|
|
No Intervention: Arm 3
Usual care group
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age of 50 years and older
- Reported pain for at least 3 months
- Mild-moderate pain severity according to the WOMAC pain scale
- Radiographic evidence of knee or hip osteoarthritis (Kellgren-Lawrence score of 2 in at least one joint)
- Community-dwelling (i.e. own home, apartment, senior residence)
- Ambulatory with or without a cane or walker
- Adequate cognition to complete study activities (score of 5 on the 6-Item Screener)
- Ability to use the Actiwatch-S (Phillips-Respironics, Mini-Mitter, Bend OR)accelerometer to record symptoms and activity patterns (ascertained by completion of a learning module specific to the use of the device in this study)
- English-speaking
Exclusion Criteria:
- Self-reported medical history of conditions with pain and/or fatigue as a known and marked symptom (e.g multiple sclerosis, rheumatoid arthritis)
- Medically unstable (e.g. acute conditions or acute presentations of chronic conditions)
- Anemia (hemoglobin of <10 for men and <11 for women)
- Unmanaged thyroid dysfunction (Thyroid stimulating hormone <.035>5.5 mg/dl)
- 2 or more days of complete bed rest within the last month
- Limb hemiplegia or amputation
- Arthroscopic procedure within the previous 2 months
- Joint injection within the previous 3 months
- Total or partial joint replacement within the previous 6 months
- Self-reported illness or conditions that impair cooperation with the study team or ability to complete study procedures
- Current enrollee in physical or occupational therapy for symptoms associated with osteoarthritis
- Current attendance or attendance within the previous year in a cognitive behavioral therapy program or other self-management program that includes activity pacing instruction
- Any other unforeseen exclusion criteria that, by the opinion of the study personnel, would make the participant unable to safely or effectively complete the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192516
Contacts
| Contact: Dana Wolford, BSH | (734) 763-5664 | Dana.Wolford@va.gov |
| Contact: Melissa Levoska, BS | (734) 763-5664 | malevos@umich.edu |
Locations
| United States, Michigan | |
| VA Ann Arbor Healthcare System | Recruiting |
| Ann Arbor, Michigan, United States, 48113 | |
| Contact: Dana Wolford, BSH 734-763-5664 Dana.Wolford@va.gov | |
| Principal Investigator: Susan L Murphy, ScD OTR | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Susan L Murphy, ScD OTR | VA Ann Arbor Healthcare System |
More Information
No publications provided by Department of Veterans Affairs
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01192516 History of Changes |
| Other Study ID Numbers: | E7557-R |
| Study First Received: | August 25, 2010 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Osteoarthritis Activity Pacing |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013