Engaging African American Older Adults With Arthritis in a Physical Activity Intervention

NCT05652413 | Completed

• 1 other identifier: Pro00108300
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (3)

• Number of enrolled participants

  Did the study reach full anticipated accrual?

  6 months

• Number of participants who completed the entire program

  Participants who complete all assessments and required study sessions

  8 weeks

• Percentage of participants who were mostly or very satisfied with the intervention

  Client Satisfaction Questionnaire asks 8 questions related to patient satisfaction on a Likert Scale of 1= very satisfied to 7 = very dissatisfied. There is one item assessing overall satisfaction with the intervention, and the percentage of participants responding to this item with "mostly" or "very" satisfied is reported below.

  Post-treatment (8 weeks)

Secondary Outcomes (10)

• Arthritis Pain (AIMS 2 Symptom Subscale)

  Baseline, post-treatment (8 weeks)

• Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)

  Baseline, post-treatment (8 weeks)

• Psychological Distress (AIMS 2 Affect Subscale)

  Baseline, post-treatment (8 weeks)

• Step Count

  Baseline, post-treatment (8 weeks)

• Rapid Assessment of Physical Activity

  Baseline, post-treatment (8 weeks)

Study Arms (1)

Adapted-Engage-PA

EXPERIMENTAL

Participants will receive two sessions, lasting 60 minutes each, of behavioral intervention strategies to increase daily walking routines and prevent pain flares.

Behavioral: Adapted-Engage-PA

Interventions

Adapted-Engage-PA BEHAVIORAL

Enhanced motivation strategies for increasing walking using personal values assessment and value-guided goal setting, adapted from Acceptance and Commitment therapy. Strategic activity pacing to increase stamina and reduce pain flares when walking, using the Activity Rest Cycle, from Pain Coping Skills Training. Culturally sensitive elements for older adults who identify as African American such as linking motivation to spirituality, family, community, and other personally-meaningful values.

Adapted-Engage-PA

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• hearing or visual impairment that would prevent ability to participate in sessions or use participant worksheets, even with use of adaptive supports/devices
• planned surgery during study duration that would limit mobility (e.g., due to recommended rehabilitation or recovery period) for more than 3 weeks
• current enrollment in cardiac rehabilitation
• myocardial infarction in the past 3 months
• major surgery requiring limited movement or mobility for recovery within the past 3 months
• presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation
• Medical provider indicating that exercise (even walking) should only be medically supervised
• fall or falls within the last 3 months that led to immediate medical treatment/hospitalization
• reported or suspected moderate or severe cognitive impairment
• brain tumor/cancer metastases to the brain
• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jennifer Plumb Vilardaga, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: January 9, 2023
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)