Trial Outcomes & Findings for Increasing Physical Activity in Older Adults With Osteoarthritis Pain: Examining a Brief Behavioral Intervention (NCT NCT04490395)

NCT ID: NCT04490395

Last Updated: 2023-01-05

Results Overview

How many participants, up to the expected 40 participants, enroll in the study within the study period

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2023-01-05

Participant Flow

Participant milestones

Measure	Engage PA Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Overall Study STARTED	19	20
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Engage PA Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Increasing Physical Activity in Older Adults With Osteoarthritis Pain: Examining a Brief Behavioral Intervention

Baseline characteristics by cohort

Measure	Engage PA n=19 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=20 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	19 Participants n=93 Participants	20 Participants n=4 Participants	39 Participants n=27 Participants
Age, Continuous	72.32 years STANDARD_DEVIATION 6.01 • n=93 Participants	71.20 years STANDARD_DEVIATION 4.42 • n=4 Participants	71.55 years STANDARD_DEVIATION 5.20 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	18 Participants n=4 Participants	33 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=93 Participants	17 Participants n=4 Participants	33 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	19 Participants n=93 Participants	20 Participants n=4 Participants	39 Participants n=27 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Expected participants.

How many participants, up to the expected 40 participants, enroll in the study within the study period

Outcome measures

Measure	Engage PA n=20 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=20 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Number of Participants Enrolled in the Study	19 Participants	20 Participants

PRIMARY outcome

Timeframe: 6 weeks

Participants who complete all assessments and required study sessions

Outcome measures

Measure	Engage PA n=19 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=20 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Number of Participants Who Completed the Entire Program	19 Participants	20 Participants

PRIMARY outcome

Timeframe: Post treatment (6 weeks)

Population: Only those receiving the active treatment (Engage PA group) were given this measure.

Client Satisfaction Questionnaire asks 12 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.

Outcome measures

Measure	Engage PA n=18 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention	89 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, post-treatment (6 weeks)

Population: Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.

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.

Outcome measures

Measure	Engage PA n=18 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=19 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Arthritis Pain (AIMS 2 Symptom Subscale) Baseline	13.72 score on a scale Standard Deviation 3.80	14.90 score on a scale Standard Deviation 4.16
Arthritis Pain (AIMS 2 Symptom Subscale) Post-Treatment	11.78 score on a scale Standard Deviation 3.69	14.58 score on a scale Standard Deviation 4.50

SECONDARY outcome

Timeframe: Baseline, post-treatment (6 weeks)

Population: Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.

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.

Outcome measures

Measure	Engage PA n=18 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=19 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale) Baseline	6.38 score on a scale Standard Deviation 1.89	7.44 score on a scale Standard Deviation 2.00
Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale) Post-Treatment	6.64 score on a scale Standard Deviation 1.38	7.51 score on a scale Standard Deviation 2.09

SECONDARY outcome

Timeframe: Baseline, post-treatment (6 weeks)

Population: Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.

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.

Outcome measures

Measure	Engage PA n=18 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=19 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Psychological Distress (AIMS 2 Affect Subscale) Baseline	10.36 score on a scale Standard Deviation 3.12	10.37 score on a scale Standard Deviation 2.85
Psychological Distress (AIMS 2 Affect Subscale) Post-treatment	10.59 score on a scale Standard Deviation 4.15	10.33 score on a scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: Baseline, post-treatment (6 weeks)

Population: Only some participants were able to record daily steps data due to complications with devices and COVID-19 protocols.

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.

Outcome measures

Measure	Engage PA n=9 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=9 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Daily Step Count in 7 Day Period Baseline	35712.55 Mean of total steps in 7 day period Standard Deviation 27441.78	28165.89 Mean of total steps in 7 day period Standard Deviation 20916.05
Daily Step Count in 7 Day Period Post-treatment	38268.56 Mean of total steps in 7 day period Standard Deviation 28154.68	28154.67 Mean of total steps in 7 day period Standard Deviation 29183.00

SECONDARY outcome

Timeframe: Baseline, post-treatment (6 weeks)

Population: Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.

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.

Outcome measures

Measure	Engage PA n=18 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=19 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Rapid Assessment of Physical Activity Baseline	3.25 score on a scale Standard Deviation 1.22	3.16 score on a scale Standard Deviation 1.50
Rapid Assessment of Physical Activity Post-treatment	3.47 score on a scale Standard Deviation 1.73	2.31 score on a scale Standard Deviation 1.19

SECONDARY outcome

Timeframe: Baseline, post-treatment (6 weeks)

Population: Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.

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.

Outcome measures

Measure	Engage PA n=18 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=19 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Psychological Flexibility Baseline	13.95 score on a scale Standard Deviation 8.20	16.21 score on a scale Standard Deviation 7.45
Psychological Flexibility Post-Treatment	14.72 score on a scale Standard Deviation 8.37	13.05 score on a scale Standard Deviation 6.31

SECONDARY outcome

Timeframe: Baseline, post-treatment (6 weeks)

Population: Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.

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.

Outcome measures

Measure	Engage PA n=18 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=19 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Valued Living - Health Domain Baseline	4.11 score on a scale Standard Deviation 2.26	4.05 score on a scale Standard Deviation 1.99
Valued Living - Health Domain Post-treatment	3.76 score on a scale Standard Deviation 1.44	4.88 score on a scale Standard Deviation 1.73

SECONDARY outcome

Timeframe: Baseline, post-treatment (6 weeks)

Population: Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.

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.

Outcome measures

Measure	Engage PA n=18 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=19 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Valued Living - Leisure Domain Baseline	4.26 score on a scale Standard Deviation 2.26	4.60 score on a scale Standard Deviation 4.18
Valued Living - Leisure Domain Post-treatment	4.12 score on a scale Standard Deviation 1.87	4.18 score on a scale Standard Deviation 2.01

SECONDARY outcome

Timeframe: Baseline, post-treatment (6 weeks)

Population: Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.

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.

Outcome measures

Measure	Engage PA n=18 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=19 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Valued Living - Relationship Domain Baseline	3.68 score on a scale Standard Deviation 2.11	4.29 score on a scale Standard Deviation 2.29
Valued Living - Relationship Domain Post-treatment	4.00 score on a scale Standard Deviation 2.10	4.35 score on a scale Standard Deviation 2.15

SECONDARY outcome

Timeframe: Baseline, post-treatment (6 weeks)

Population: Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.

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.

Outcome measures

Measure	Engage PA n=18 Participants Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.	Treatment as Usual Plus Fitness Tracker n=19 Participants Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
Valued-Living - Work/Community Domain Baseline	3.32 score on a scale Standard Deviation 1.97	3.30 score on a scale Standard Deviation 1.87
Valued-Living - Work/Community Domain Post-Treatment	3.65 score on a scale Standard Deviation 2.03	3.41 score on a scale Standard Deviation 2.24

Adverse Events

Engage PA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual Plus Fitness Tracker

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Plumb Vilardaga, PhD

Duke University

Phone: 919-668-6123

Email: jennifer.plumb.vilardaga@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place