Mobile Motivational Physical Activity Targeted Intervention

Osteoarthritis Clinical Trial

— MobMPATI  

Official title:

Mobile Motivational Physical Activity Targeted Intervention (MobMPATI) to Improve Sleep in Older Adults With Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160287
• Other study ID #: 52062
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. Test the acceptability of MobMPATI for older adults with OA and poor sleep quality as a manifestation of sleep deficiency.

2. Test the feasibility of implementing MobMPATI for older adults with OA, as well as collecting electronic data from the sample.

3. Explore pre/posttest changes in self-efficacy, motivation and sleep deficiency measures [total sleep time (TST) and sleep efficiency (SE)] with the MobMPATI intervention.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 30, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported
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	Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported
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	Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported
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	Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported
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	Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported