Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
Keywords
Engage PA, treatment as usual
Brief summary
The purpose of this study is to evaluate how older adults might benefit from sessions that teach behavioral coping skills for increasing physical activity and reducing interference from arthritis pain. This study will randomize individuals to receive Engage-PA, or continue to receive treatment as usual. Engage-PA involves two sessions (about 45 minutes each) with a study therapist that teaches individuals behavioral skills for increasing daily steps. These behavioral skills include identifying their personal values and instructions on how to pace their daily physical activity to avoid creating severe pain when walking. All participants in the study will wear small devices that track physical activity such as daily steps throughout the study, which also allow participants to see their daily step counts and overall level of activity. All participants will answer a set of questions about how much arthritis gets the way of many important life activities, their success at living in line with their personal values, and how much thoughts, feelings and body sensations get in the way of living a satisfying life. These questions will be asked at the beginning of the study and 6 weeks into the study.
Interventions
BEHAVIORALEngage 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.
OTHERTreatment 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.
Sponsors
National Institute on Aging (NIA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65 or older * English speaking * Diagnosis of osteoarthritis in knee or hip * Able to ambulate even if assisted with ambulatory device such as walker or cane * Endorse worst pain and pain interference as ≥ 3 out of 10 within the last week
Exclusion criteria
* 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) indicated by medical chart, treating medical provider or other staff, or study staff interactions that would contraindicate safe study participation * Medical provider indicating that exercise (even walking) should only be medically supervised; as determined by medical record review or patient reported * Fall or falls within the last 3 months that led to immediate medical treatment/hospitalization * Reported or suspected moderate or severe cognitive impairment subsequently informed by a Folstein Mini-Mental Status Examination of \<19
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Enrolled in the Study | 9 months | How many participants, up to the expected 40 participants, enroll in the study within the study period |
| Number of Participants Who Completed the Entire Program | 6 weeks | Participants who complete all assessments and required study sessions |
| Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention | Post treatment (6 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Step Count in 7 Day Period | Baseline, post-treatment (6 weeks) | 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. |
| Rapid Assessment of Physical Activity | Baseline, post-treatment (6 weeks) | 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. |
| Psychological Flexibility | Baseline, post-treatment (6 weeks) | 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. |
| Arthritis Pain (AIMS 2 Symptom Subscale) | Baseline, post-treatment (6 weeks) | 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. |
| Valued Living - Leisure Domain | Baseline, post-treatment (6 weeks) | 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. |
| Valued Living - Relationship Domain | Baseline, post-treatment (6 weeks) | 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. |
| Valued-Living - Work/Community Domain | Baseline, post-treatment (6 weeks) | 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. |
| Valued Living - Health Domain | Baseline, post-treatment (6 weeks) | 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. |
| Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale) | Baseline, post-treatment (6 weeks) | 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. |
| Psychological Distress (AIMS 2 Affect Subscale) | Baseline, post-treatment (6 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 20 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Engage PA | Treatment as Usual Plus Fitness Tracker | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 20 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 72.32 years STANDARD_DEVIATION 6.01 | 71.20 years STANDARD_DEVIATION 4.42 | 71.55 years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 17 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 12 Participants | 24 Participants |
| Region of Enrollment United States | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Number of Participants Enrolled in the Study
How many participants, up to the expected 40 participants, enroll in the study within the study period
Time frame: 9 months
Population: Expected participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engage PA | Number of Participants Enrolled in the Study | 19 Participants |
| Treatment as Usual Plus Fitness Tracker | Number of Participants Enrolled in the Study | 20 Participants |
Primary
Number of Participants Who Completed the Entire Program
Participants who complete all assessments and required study sessions
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engage PA | Number of Participants Who Completed the Entire Program | 19 Participants |
| Treatment as Usual Plus Fitness Tracker | Number of Participants Who Completed the Entire Program | 20 Participants |
Primary
Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention
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.
Time frame: Post treatment (6 weeks)
Population: Only those receiving the active treatment (Engage PA group) were given this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Engage PA | Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention | 89 percentage of participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage PA | Arthritis Pain (AIMS 2 Symptom Subscale) | Baseline | 13.72 score on a scale | Standard Deviation 3.8 |
| Engage PA | Arthritis Pain (AIMS 2 Symptom Subscale) | Post-Treatment | 11.78 score on a scale | Standard Deviation 3.69 |
| Treatment as Usual Plus Fitness Tracker | Arthritis Pain (AIMS 2 Symptom Subscale) | Baseline | 14.90 score on a scale | Standard Deviation 4.16 |
| Treatment as Usual Plus Fitness Tracker | Arthritis Pain (AIMS 2 Symptom Subscale) | Post-Treatment | 14.58 score on a scale | Standard Deviation 4.5 |
p-value: 0.04495% CI: [-0.26, 3.62]t-test, 2 sided
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage PA | Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale) | Baseline | 6.38 score on a scale | Standard Deviation 1.89 |
| Engage PA | Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale) | Post-Treatment | 6.64 score on a scale | Standard Deviation 1.38 |
| Treatment as Usual Plus Fitness Tracker | Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale) | Baseline | 7.44 score on a scale | Standard Deviation 2 |
| Treatment as Usual Plus Fitness Tracker | Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale) | Post-Treatment | 7.51 score on a scale | Standard Deviation 2.09 |
p-value: 0.05695% CI: [-0.15, 1.33]t-test, 2 sided
Secondary
Daily Step Count in 7 Day Period
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage PA | Daily Step Count in 7 Day Period | Baseline | 35712.55 Mean of total steps in 7 day period | Standard Deviation 27441.78 |
| Engage PA | Daily Step Count in 7 Day Period | Post-treatment | 38268.56 Mean of total steps in 7 day period | Standard Deviation 28154.68 |
| Treatment as Usual Plus Fitness Tracker | Daily Step Count in 7 Day Period | Baseline | 28165.89 Mean of total steps in 7 day period | Standard Deviation 20916.05 |
| Treatment as Usual Plus Fitness Tracker | Daily Step Count in 7 Day Period | Post-treatment | 28154.67 Mean of total steps in 7 day period | Standard Deviation 29183 |
Comparison: Only 9 cases had any data available per group, and some had missing values and were not included in each analysis.p-value: 0.258ANOVA
p-value: 0.627ANOVA
Comparison: Time x Condition interactionp-value: 0.947ANOVA
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage PA | Psychological Distress (AIMS 2 Affect Subscale) | Baseline | 10.36 score on a scale | Standard Deviation 3.12 |
| Engage PA | Psychological Distress (AIMS 2 Affect Subscale) | Post-treatment | 10.59 score on a scale | Standard Deviation 4.15 |
| Treatment as Usual Plus Fitness Tracker | Psychological Distress (AIMS 2 Affect Subscale) | Baseline | 10.37 score on a scale | Standard Deviation 2.85 |
| Treatment as Usual Plus Fitness Tracker | Psychological Distress (AIMS 2 Affect Subscale) | Post-treatment | 10.33 score on a scale | Standard Deviation 2.18 |
p-value: 0.37795% CI: [-1.75, 1.28]t-test, 2 sided
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage PA | Psychological Flexibility | Baseline | 13.95 score on a scale | Standard Deviation 8.2 |
| Engage PA | Psychological Flexibility | Post-Treatment | 14.72 score on a scale | Standard Deviation 8.37 |
| Treatment as Usual Plus Fitness Tracker | Psychological Flexibility | Baseline | 16.21 score on a scale | Standard Deviation 7.45 |
| Treatment as Usual Plus Fitness Tracker | Psychological Flexibility | Post-Treatment | 13.05 score on a scale | Standard Deviation 6.31 |
p-value: 0.0795% CI: [-6.05, 0.94]t-test, 2 sided
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage PA | Rapid Assessment of Physical Activity | Baseline | 3.25 score on a scale | Standard Deviation 1.22 |
| Engage PA | Rapid Assessment of Physical Activity | Post-treatment | 3.47 score on a scale | Standard Deviation 1.73 |
| Treatment as Usual Plus Fitness Tracker | Rapid Assessment of Physical Activity | Baseline | 3.16 score on a scale | Standard Deviation 1.5 |
| Treatment as Usual Plus Fitness Tracker | Rapid Assessment of Physical Activity | Post-treatment | 2.31 score on a scale | Standard Deviation 1.19 |
p-value: 0.03895% CI: [-1.85, 0.98]t-test, 2 sided
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage PA | Valued Living - Health Domain | Baseline | 4.11 score on a scale | Standard Deviation 2.26 |
| Engage PA | Valued Living - Health Domain | Post-treatment | 3.76 score on a scale | Standard Deviation 1.44 |
| Treatment as Usual Plus Fitness Tracker | Valued Living - Health Domain | Baseline | 4.05 score on a scale | Standard Deviation 1.99 |
| Treatment as Usual Plus Fitness Tracker | Valued Living - Health Domain | Post-treatment | 4.88 score on a scale | Standard Deviation 1.73 |
p-value: 0.4395% CI: [-1.19, 1.42]t-test, 2 sided
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage PA | Valued Living - Leisure Domain | Baseline | 4.26 score on a scale | Standard Deviation 2.26 |
| Engage PA | Valued Living - Leisure Domain | Post-treatment | 4.12 score on a scale | Standard Deviation 1.87 |
| Treatment as Usual Plus Fitness Tracker | Valued Living - Leisure Domain | Baseline | 4.60 score on a scale | Standard Deviation 4.18 |
| Treatment as Usual Plus Fitness Tracker | Valued Living - Leisure Domain | Post-treatment | 4.18 score on a scale | Standard Deviation 2.01 |
p-value: 0.7295% CI: [-0.194, 1.42]t-test, 2 sided
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage PA | Valued Living - Relationship Domain | Post-treatment | 4.00 score on a scale | Standard Deviation 2.1 |
| Engage PA | Valued Living - Relationship Domain | Baseline | 3.68 score on a scale | Standard Deviation 2.11 |
| Treatment as Usual Plus Fitness Tracker | Valued Living - Relationship Domain | Baseline | 4.29 score on a scale | Standard Deviation 2.29 |
| Treatment as Usual Plus Fitness Tracker | Valued Living - Relationship Domain | Post-treatment | 4.35 score on a scale | Standard Deviation 2.15 |
p-value: 0.34195% CI: [-0.35, 0.23]t-test, 2 sided
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engage PA | Valued-Living - Work/Community Domain | Baseline | 3.32 score on a scale | Standard Deviation 1.97 |
| Engage PA | Valued-Living - Work/Community Domain | Post-Treatment | 3.65 score on a scale | Standard Deviation 2.03 |
| Treatment as Usual Plus Fitness Tracker | Valued-Living - Work/Community Domain | Baseline | 3.30 score on a scale | Standard Deviation 1.87 |
| Treatment as Usual Plus Fitness Tracker | Valued-Living - Work/Community Domain | Post-Treatment | 3.41 score on a scale | Standard Deviation 2.24 |
p-value: 0.2595% CI: [-2.35, 1.17]t-test, 2 sided