An interventional study of Motivaltional interviews and infrequent motivational text messages in Osteoarthritis, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 24 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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>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).
Multidimensional, tailored intervention for sleep deficiency in for older adults with OA
Behavioral: 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
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
Time frame: 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
Time frame: 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 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
Time frame: 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
Time frame: 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
Time frame: Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported
| Milestone | Motivational Interview and Text Messages |
|---|---|
| Started | 24 |
| Completed | 22 |
| Not completed | 2 |
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
| units on a scale | Motivational Interview and Text Messages |
|---|---|
| Mixed Effect Model Inferential Estimates of Longitudinal Changes Across 3 Time Points (Baseline, Week 14, Week 19) in Insomnia Severity Index | -1.24 (-2.43 to -0.05) |
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
| minutes | Motivational Interview and Text Messages |
|---|---|
| Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time Points (Baseline, Week 14, Week 19) in Actigraphy Total Sleep Time (TST) | -4.5 (-13.4 to 4.4) |
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
| score on a scale | Motivational Interview and Text Messages |
|---|---|
| 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 (-0.07 to 0.63) |
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
| score on a scale | Motivational Interview and Text Messages |
|---|---|
| Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Pain Score | -0.13 (-0.47 to 0.20) |
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
| step count | Motivational Interview and Text Messages |
|---|---|
| Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Objectively Measured Step Count | 45.6 (-311.6 to 402.9) |
Collected over 5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Motivational Interview and Text Messages | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | Motivational Interview and Text Messages |
|---|---|
| Mean | 71 ± 4 |
| Sex: Female, Male(Participants) | Motivational Interview and Text Messages |
|---|---|
| Female | 17 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | Motivational Interview and Text Messages |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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