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More than 50% of older persons with osteoarthritis (OA) experience disrupted sleep and insomnia symptoms of difficulty falling asleep, awakening during the night, and awakening too early and being unable to fall back to sleep. Because OA pain has been implicated in sleep problems and because physical exercise interventions have been found to improve pain and sleep quality, staying physically active during the daytime is likely advantageous in terms of improving sleep. Physical exercise interventions with a duration between 10 and 16 weeks have been shown to improve quality of sleep in older adults with self-reported disrupted sleep. Unfortunately, recent reports show that older adults with OA are mainly sedentary and few meet national guidelines for recommended amounts of daily physical activity. A self-management intervention that integrates 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.
The proposed study will involve delivery of automatic physical activity-focused text messages, a novel sleep self-management diary (SleepTight) and motivational interviewing in participants with OA of the hip or knee (most commonly affected joints). The purpose of this Project is to pilot test a new self-management program: MobMPATI, a multidimensional, tailored intervention for sleep deficiency in for older adults with OA. The specific aims are to:
This study will provide feasibility/acceptability and preliminary data necessary for a larger clinical trial of MobMPATI intervention to encourage physical activity and reduce sedentary behavior in older adults with OA as a way of reducing sleep deficiency. Preliminary testing of the intervention will indicate what measures are more sensitive in promoting self-efficacy and motivation so that a smaller number of outcomes could be monitored to reduce participant burden. This study is the first step in this innovative program of research. The knowledge gained will provide data on the benefit of a potentially cost-effective intervention that could be implemented on a large scale to improve health of older adults with OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational interview and text messages | Experimental | Multidimensional, tailored intervention for sleep deficiency in for older adults with OA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivaltional interviews and infrequent motivational text messages | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mixed Effect Model Inferential Estimates of Longitudinal Changes Across 3 Time Points (Baseline, Week 14, Week 19) in Insomnia Severity Index | 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 | Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported |
| Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time Points (Baseline, Week 14, Week 19) in Actigraphy Total Sleep Time (TST) | 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 | Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
>65 years of age
Clinically diagnosed OA of hip or knee
Positive for sleep deficiency, defined as Insomnia Severity Index>=12
Low physical activity based on Rapid Assessment of Physical Activity <=2
Stable use of pain, sleep and/or mood regulating medications over the past month
Resides in Seattle metropolitan area
Exclusion Criteria:
Acute injury associated with hip or knee pain
Inability to stand up without assistance
Memory Impairment Screen for Telephone (MIS-T) score of <4, suggesting cognitive impairment
Severe hearing or visual impairment
An acute episode or change in the treatment of psychiatric problems within the past 3 months
Diagnosed sleep disorder (e.g., sleep disordered breathing; insomnia).
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| Name | Affiliation | Role |
|---|---|---|
| Oleg Zaslavsky | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mixed Effect Model Inferential Estimates of Longitudinal Changes Across 3 Time Points (Baseline, Week 14, Week 19) in Insomnia Severity Index | 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 | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported |
|
5 months
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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 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oleg Zaslavsky | University of Washington | 2066163242 | ozasl@uw.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 | May 18, 2017 | Apr 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported |
| Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Pain Score | 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 | Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported |
| Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Objectively Measured Step Count | 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 | Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | 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
|
|
| Primary | Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time Points (Baseline, Week 14, Week 19) in Actigraphy Total Sleep Time (TST) | 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 | 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) | Posted | Mean | 95% Confidence Interval | minutes | Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported |
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| Secondary | 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 | 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 | 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported |
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| Secondary | Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Pain Score | 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 | 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported |
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| Secondary | Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Objectively Measured Step Count | 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 | 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) | Posted | Mean | 95% Confidence Interval | step count | Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| D001519 |
| Behavior |