Osteoarthritis, KneeNCT05652413
Engaging African American Older Adults With Arthritis in a Physical Activity Intervention
A study testing Adapted-Engage-PA in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Adapted-Engage-PA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Recruitment and Engagement of African American Older Adults With Osteoarthritis Pain in a Behavioral Pain Management and Physical Activity Intervention
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Adapted-Engage-PA
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted-Engage-PABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Adapted-Engage-PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of enrolled participants
Did the study reach full anticipated accrual?
Measured: 6 months
Number of participants who completed the entire program
Participants who complete all assessments and required study sessions
Measured: 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.
Measured: Post-treatment (8 weeks)
Secondary outcomes (10)
Arthritis Pain (AIMS 2 Symptom Subscale)
The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living both with a total score and on several subscales (i.e., pain severity, physical functioning/pain- related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Symptom subscale includes items assessing pain severity, stiffness, and physical discomfort. Range is 5 to 25 where higher scores indicate worse functioning.
Measured: Baseline, post-treatment (8 weeks)
Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)
The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Physical functioning subscale includes items assessing mobility level, walking and bending, self-care and household tasks. Range is 5-25 where higher scores indicate worse functioning.
Measured: Baseline, post-treatment (8 weeks)
Psychological Distress (AIMS 2 Affect Subscale)
The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Psychological distress subscale includes items assessing mood and anxiety/tension. Range is 5-25 where higher scores indicate worse functioning.
Measured: Baseline, post-treatment (8 weeks)
Step Count
Daily step counts as reported to study staff, after participants recorded them from wearable fitness trackers at end of day. Each assessment period consisted of 7 continuous days of wear. Summed totals of steps in the 7 day period were calculated, and then means calculated between groups of these summed step counts for the 7 day assessment period.
Measured: Baseline, post-treatment (8 weeks)
Rapid Assessment of Physical Activity
The RAPA is a self-reported measure that assesses participants engagement in a variety of activities, such as light movement, moderate activity, vigorous activity, and other activities such as strength-training or yoga. Scores range from 0 - 7, where higher scores indicate greater involvement in physical activity overall.
Measured: Baseline, post-treatment (8 weeks)
Psychological Flexibility
The Acceptance and Action Questionnaire-II asks about psychological flexibility, defined as how often thoughts, feelings and body sensations get in the way of living a fulfilling life. Responses are on a 1 to 7 Likert scale with 1 indicating that these issues never get in the way, and 7 indicating that these issues always get in the way. Range is 7 - 49, with lower scores indicating better outcomes.
Title: Psychological Flexibility The Acceptance and Action Questionnaire-II asks about psychological flexibility, defined as how often thoughts, feelings and body sensations get in the way of living a fulfilling life. Responses are on a 1 to 7 Likert scale with 1 indicating that these issues never get in the way, and 7 indicating that these issues always get in the way. Range is 7 - 49, with lower scores indicating better outcomes.
Measured: Baseline, post-treatment (8 weeks)
Valued Living - Health Domain
The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful. Range for each domain is 1 - 14 with lower as better outcome.
Measured: Baseline, post-treatment (8 weeks)
Valued Living - Leisure Domain
The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful. Range for each domain is 1 - 14 with lower as better outcome.
Measured: Baseline, post-treatment (8 weeks)
Valued Living -Relationship Domain
The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful. Range for each domain is 1 - 14 with lower as better outcome.
Measured: Baseline, post-treatment (8 weeks)
Valued Living -Work/Community Domain
The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful. Range for each domain is 1 - 14 with lower as better outcome.
Measured: Baseline, post-treatment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start9 Jan 2023
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Plumb Vilardaga, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652413
- Sponsor's protocol ID
- Pro00108300
- Status last verified
- Jul 2023
- First submitted
- 7 Dec 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Recruitment and Engagement of African American Older Adults With Osteoarthritis Pain in a Behavioral Pain Management and Physical Activity Intervention
- ClinicalTrials.gov ID
- NCT05652413
- Acronym / sponsor ID
- Pro00108300
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adapted-Engage-PA | Experimental | Behavioral: Adapted-Engage-PAParticipants will receive two sessions, lasting 60 minutes each, of behavioral intervention strategies to increase daily walking routines and prevent pain flares. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted-Engage-PAEnhanced 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. | Behavioural | Adapted-Engage-PA |
Primary outcome
Number of enrolled participants
Time frame: 6 months
Did the study reach full anticipated accrual?
Number of participants who completed the entire program
Time frame: 8 weeks
Participants who complete all assessments and required study sessions
Percentage of participants who were mostly or very satisfied with the intervention
Time frame: Post-treatment (8 weeks)
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.
10 secondary outcomes
Arthritis Pain (AIMS 2 Symptom Subscale)
Time frame: Baseline, post-treatment (8 weeks)
Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)
Time frame: Baseline, post-treatment (8 weeks)
Psychological Distress (AIMS 2 Affect Subscale)
Time frame: Baseline, post-treatment (8 weeks)
Step Count
Time frame: Baseline, post-treatment (8 weeks)
Rapid Assessment of Physical Activity
Time frame: Baseline, post-treatment (8 weeks)
Psychological Flexibility
Time frame: Baseline, post-treatment (8 weeks)
Valued Living - Health Domain
Time frame: Baseline, post-treatment (8 weeks)
Valued Living - Leisure Domain
Time frame: Baseline, post-treatment (8 weeks)
Valued Living -Relationship Domain
Time frame: Baseline, post-treatment (8 weeks)
Valued Living -Work/Community Domain
Time frame: Baseline, post-treatment (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Plumb Vilardaga, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted-Engage-PA in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of enrolled participants (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.