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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engage PA | Experimental |
| |
| Treatment as usual plus fitness tracker | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engage PA | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled in the Study | How many participants, up to the expected 40 participants, enroll in the study within the study period | 9 months |
| Number of Participants Who Completed the Entire Program | Participants who complete all assessments and required study sessions | 6 weeks |
| 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. | Post treatment (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Plumb Vilardaga, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35915512 | Derived | Plumb Vilardaga JC, Kelleher SA, Diachina A, Riley J, Somers TJ. Linking physical activity to personal values: feasibility and acceptability randomized pilot of a behavioral intervention for older adults with osteoarthritis pain. Pilot Feasibility Stud. 2022 Aug 1;8(1):164. doi: 10.1186/s40814-022-01121-0. | |
| 35018370 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Treatment as Usual Plus Fitness Tracker |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Expected participants. | Posted | Count of Participants | Participants | 9 months |
|
Approximately 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Changes to measurement type during trial due to pandemic-related challenges (no objective daily steps data available despite intention to collect this data).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Plumb Vilardaga, PhD | Duke University | 919-668-6123 | jennifer.plumb.vilardaga@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2022 | Oct 5, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2021 | Nov 29, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual plus (TAU+) | Other | 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. |
|
| Baseline, post-treatment (6 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. | Baseline, post-treatment (6 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. | Baseline, post-treatment (6 weeks) |
| 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. | Baseline, post-treatment (6 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. | Baseline, post-treatment (6 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. | Baseline, post-treatment (6 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. | Baseline, post-treatment (6 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. | Baseline, post-treatment (6 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. | Baseline, post-treatment (6 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. | Baseline, post-treatment (6 weeks) |
| Vilardaga JCP, Kelleher S, Diachina A, Riley J, Somers T. Linking Physical Activity to Personal Values: Feasibility and Acceptability Randomized Pilot of a Behavioral Intervention for Older Adults with Osteoarthritis Pain. Res Sq [Preprint]. 2022 Jan 3:rs.3.rs-1182374. doi: 10.21203/rs.3.rs-1182374/v1. |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants Who Completed the Entire Program | Participants who complete all assessments and required study sessions | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 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. | Only those receiving the active treatment (Engage PA group) were given this measure. | Posted | Number | percentage of participants | Post treatment (6 weeks) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment (6 weeks) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment (6 weeks) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment (6 weeks) |
|
|
|
|
| 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. | Only some participants were able to record daily steps data due to complications with devices and COVID-19 protocols. | Posted | Mean | Standard Deviation | Mean of total steps in 7 day period | Baseline, post-treatment (6 weeks) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment (6 weeks) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment (6 weeks) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment (6 weeks) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment (6 weeks) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment (6 weeks) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-treatment (6 weeks) |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D012216 |
| Rheumatic Diseases |
| ANOVA |
| 0.627 |
| F test (1,15) df |
| 0.246 |
| 2-Sided |
| Superiority |
Between group analysis |
Between group analysis |
| Time x Condition interaction | ANOVA | 0.947 | F test (1,15) df | 0.005 | 2-Sided | Superiority | Time x Condition interaction |