Clinical trial NCT05652413: Engaging African American Older Adults With Arthritis in a Physical Activity Intervention
Official title: Enhancing Recruitment and Engagement of African American Older Adults With Osteoarthritis Pain in a Behavioral Pain Management and Physical Activity Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Physical activity like walking is one important way to reduce pain and improve wellbeing for older adults with knee and hip arthritis, but most older adults and particularly those who identify as African American struggle to walk regularly. Many African Americans with arthritis have worse outcomes (like worse pain, worse overall health) than other racial and ethnic groups for many reasons including racist policies and ideas that make getting good health care more difficult. It is therefore most important to identify ways to help older adults who identify as African American improve their arthritis pain and improve their daily steps. The current study is designed to learn about older African American's preferences for a brief behavioral intervention to increase daily steps and reduce pain, and to learn about the barriers (things that make walking harder) and facilitators (things that make walking easier) for walking that they experience. Interviews with both patients and healthcare providers will provide important information that will be used to adapt an existing behavioral intervention designed to help patients increase their daily steps and reduce their arthritis pain. The final adapted intervention will be tested in a small clinical trial with older adults who identify as African American to see if it can reduce pain and increase walking over time.

Detailed description: Osteoarthritis is one of the most common risk factors for disability for African American older adults. Older adults who identify as African American experience more severe arthritis, higher pain levels, more pain related interference, more health problems that occur alongside arthritis, and have greater problems accessing appropriate and timely care for arthritis than other racial and ethnic groups. Physical activity can help improve pain and is safe even for older adults, but few older adults walk regularly due to pain, psychological distress, and other environmental barriers for walking. Specific strategies targeted to support older African Americans in walking more are needed. A previously tested behavioral intervention called Engage-PA has shown promise for supporting older adults with arthritis in the knee and/or hip. Yet little is know about how promising this intervention is for older African Americans, nor the specific barriers and facilitators for walking more for this population. Some specific components of Engage-PA may be particularly culturally-relevant for older African Americans, such as the use of personal values, or a detailed discussion of personally-identified meaning and purpose linked to daily walking routines. Older African Americans with arthritis and primary care providers treating arthritis at Duke Health have provided interview data to assist researchers in adapting Engage-PA to be more culturally sensitive. Adapted-Engage-PA will be tested with older African Americans who have knee and/or hip pain from osteoarthritis in a small feasibility and acceptability trial.

Eligibility criteria: Inclusion Criteria:

1. age 65 or older
2. English speaking
3. identify as Black/African American
4. diagnosis of osteoarthritis in knee or hip
5. able to ambulate even if assisted with walker or cane
6. endorse worst pain and pain interference as ≥ 3 out of 10 within the last week

Exclusion Criteria:

1. hearing or visual impairment that would prevent ability to participate in sessions or use participant worksheets, even with use of adaptive supports/devices
2. planned surgery during study duration that would limit mobility (e.g., due to recommended rehabilitation or recovery period) for more than 3 weeks
3. current enrollment in cardiac rehabilitation
4. myocardial infarction in the past 3 months
5. major surgery requiring limited movement or mobility for recovery within the past 3 months
6. presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation
7. Medical provider indicating that exercise (even walking) should only be medically supervised
8. fall or falls within the last 3 months that led to immediate medical treatment/hospitalization
9. reported or suspected moderate or severe cognitive impairment
10. brain tumor/cancer metastases to the brain
11. no other conditions that would preclude safe participation (e.g., unmanaged heart conditions, neurodegenerative condition, unmanaged diabetes, severe respiratory disease), as screened the Physical Activity Readiness Questionnaire (PAR-Q+ 2020, a measure widely utilized by the U.S. National Academy of Sports Medicine and the Public Health Agency of Canada). Answers to the PARQ+2020 may result in review by patient physicians for safety prior to enrollment.

Primary outcomes:
measure: Number of enrolled participants
timeFrame: 6 months
measure: Number of participants who completed the entire program
timeFrame: 8 weeks
measure: Percentage of participants who were mostly or very satisfied with the intervention
timeFrame: Post-treatment (8 weeks)
Secondary outcomes:
measure: Arthritis Pain (AIMS 2 Symptom Subscale)
timeFrame: Baseline, post-treatment (8 weeks)
measure: Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)
timeFrame: Baseline, post-treatment (8 weeks)
measure: Psychological Distress (AIMS 2 Affect Subscale)
timeFrame: Baseline, post-treatment (8 weeks)
measure: Step Count
timeFrame: Baseline, post-treatment (8 weeks)
measure: Rapid Assessment of Physical Activity
timeFrame: Baseline, post-treatment (8 weeks)
measure: Psychological Flexibility
timeFrame: Baseline, post-treatment (8 weeks)
measure: Valued Living - Health Domain
timeFrame: Baseline, post-treatment (8 weeks)
measure: Valued Living - Leisure Domain
timeFrame: Baseline, post-treatment (8 weeks)
measure: Valued Living -Relationship Domain
timeFrame: Baseline, post-treatment (8 weeks)
measure: Valued Living -Work/Community Domain
timeFrame: Baseline, post-treatment (8 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Jennifer Plumb Vilardaga, PhD
role: PRINCIPAL_INVESTIGATOR
References: