Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Fatigue- Brief Fatigue Inventory (BFI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Arm 1
Tailored activity pacing
干预措施: Tailored Activity Pacing (Behavioral)
Arm 2
General activity pacing and symptom management (Occupational therapy)
干预措施: General Activity Pacing (Behavioral)
Arm 3
Usual care group
结局指标
主要结局
Fatigue- Brief Fatigue Inventory (BFI)
时间窗: Baseline
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.
Fatigue-BFI
时间窗: 6 months post-baseline
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.
Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Baseline
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.
Pain- WOMAC
时间窗: 6 months post baseline
This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.
Fatigue-BFI
时间窗: 10 weeks post-baseline
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.
Pain- WOMAC
时间窗: 10 weeks post-baseline
This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.
次要结局
- Physical Function- Six Minute Walk(6 months post baseline)
- Physical Function- Six Minute Walk(Baseline)
- Physical Function- Six Minute Walk(10 weeks post-baseline)