Trial Outcomes & Findings for Mobile Motivational Physical Activity Targeted Intervention (NCT NCT03160287)
NCT ID: NCT03160287
Last Updated: 2023-04-25
Results Overview
Insomnia Severity Index (ISS) Score range 0 to 28 at each time point, with higher scores indicating more severe insomnia symptoms A single value for change in ISS across three-time points was calculated using linear mixed effect modeling
COMPLETED
NA
24 participants
Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported
2023-04-25
Participant Flow
Participant milestones
| Measure |
Motivational Interview and Text Messages
Multidimensional, tailored intervention for sleep deficiency in for older adults with OA
Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA
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|---|---|
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Overall Study
STARTED
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24
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Overall Study
COMPLETED
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22
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Motivational Physical Activity Targeted Intervention
Baseline characteristics by cohort
| Measure |
Motivational Interview and Text Messages
n=24 Participants
Multidimensional, tailored intervention for sleep deficiency in for older adults with OA
Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA
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|---|---|
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Age, Continuous
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71 years
STANDARD_DEVIATION 4 • n=99 Participants
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Sex: Female, Male
Female
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17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
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7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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|
Race (NIH/OMB)
White
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23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reportedPopulation: Mixed effect models were utilized because of the time repeated structure of the data. Data collection occasions were also entered in the models to account for change over time. The adjusted for age and gender main effects for time for the ISS was tested for significance and reported as estimates and 95% confidence intervals (CI)
Insomnia Severity Index (ISS) Score range 0 to 28 at each time point, with higher scores indicating more severe insomnia symptoms A single value for change in ISS across three-time points was calculated using linear mixed effect modeling
Outcome measures
| Measure |
Motivational Interview and Text Messages
n=24 Participants
Multidimensional, tailored intervention for sleep deficiency in for older adults with OA
Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA
|
|---|---|
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Mixed Effect Model Inferential Estimates of Longitudinal Changes Across 3 Time Points (Baseline, Week 14, Week 19) in Insomnia Severity Index
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-1.24 units on a scale
Interval -2.43 to -0.05
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PRIMARY outcome
Timeframe: Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reportedPopulation: Mixed effect models were utilized because of the time repeated structure of the data. Data collection occasions were also entered in the models to account for change over time. The adjusted for age and gender main effects for time for the TST was tested for significance and reported as estimates and 95% confidence intervals (CI)
Actigraphy Total Sleep Time (TST) in minutes was calculated using baseline, week 14, and week 19 data from a wrist-worn actigraph A single value for change in TST across three-time points was calculated using linear mixed effect modeling A negative change score indicates lower TST ( in min) over time
Outcome measures
| Measure |
Motivational Interview and Text Messages
n=24 Participants
Multidimensional, tailored intervention for sleep deficiency in for older adults with OA
Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA
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|---|---|
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Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time Points (Baseline, Week 14, Week 19) in Actigraphy Total Sleep Time (TST)
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-4.5 minutes
Interval -13.4 to 4.4
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SECONDARY outcome
Timeframe: Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reportedPopulation: Mixed effect models were utilized because of the time repeated structure of the data. Data collection occasions were also entered in the models to account for change over time. The adjusted for age and gender main effects for time for the self-efficacy was tested for significance and reported as estimates and 95% confidence intervals (CI)
Self-Efficacy to Manage Chronic Disease Scale Score range 1 to 10, with higher scores indicating better efficacy. A single value for change in SE across three-time points was calculated using linear mixed effect modeling Positive change score indicates an improvement in self-efficacy over time
Outcome measures
| Measure |
Motivational Interview and Text Messages
n=24 Participants
Multidimensional, tailored intervention for sleep deficiency in for older adults with OA
Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA
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|---|---|
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Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Self-Efficacy (SE) to Manage Chronic Disease Scale
|
0.28 score on a scale
Interval -0.07 to 0.63
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SECONDARY outcome
Timeframe: Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reportedPopulation: Mixed effect models were utilized because of the time repeated structure of the data. Data collection occasions were also entered in the models to account for change over time. The adjusted for age and gender main effects for time for the pain scores was tested for significance and reported as estimates and 95% confidence intervals (CI)
Pain Score range 1 to 10, with higher scores indicating worse symptoms. A single value for change in pain across three-time points was calculated using linear mixed effect modeling Positive change score indicates worsening in pain over time
Outcome measures
| Measure |
Motivational Interview and Text Messages
n=24 Participants
Multidimensional, tailored intervention for sleep deficiency in for older adults with OA
Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA
|
|---|---|
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Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Pain Score
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-0.13 score on a scale
Interval -0.47 to 0.2
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SECONDARY outcome
Timeframe: Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reportedPopulation: Mixed effect models were utilized because of the time repeated structure of the data. Data collection occasions were also entered in the models to account for change over time. The adjusted for age and gender main effects for time for the step count was tested for significance and reported as estimates and 95% confidence intervals (CI)
Fitbit devices were used to measure weekly step count at baseline, and week 14, and week 19 A single value for change in step count across three-time points was calculated using linear mixed effect modeling A positive change indicates increased step count over time
Outcome measures
| Measure |
Motivational Interview and Text Messages
n=24 Participants
Multidimensional, tailored intervention for sleep deficiency in for older adults with OA
Motivaltional interviews and infrequent motivational text messages: A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA
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|---|---|
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Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Objectively Measured Step Count
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45.6 step count
Interval -311.6 to 402.9
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Adverse Events
Motivational Interview and Text Messages
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place