NCT03160287: MobMPATI

Mobile Motivational Physical Activity Targeted Intervention

Completed NA Results posted Last updated 25 April 2023

What this trial tests

NA trial testing Motivaltional interviews and infrequent motivational text messages in Osteoarthritis in 24 participants. Completed in 30 September 2018.

Timeline

1 June 2017

Primary endpoint
31 August 2018

30 September 2018

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 June 2017
Primary completion	31 August 2018
Estimated completion	30 September 2018
Sites	1 location across United States

Drugs / interventions tested

• Motivaltional interviews and infrequent motivational text messages

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

University of Washington

Who can join

65 and older, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mixed Effect Model Inferential Estimates of Longitudinal Changes Across 3 Time Points (Baseline, Week 14, Week 19) in Insomnia Severity Index Primary · Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported

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

Group	Value	95% CI
Motivational Interview and Text Messages	-1.24	-2.43 – -0.05

Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time Points (Baseline, Week 14, Week 19) in Actigraphy Total Sleep Time (TST) Primary · Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported

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

Group	Value	95% CI
Motivational Interview and Text Messages	-4.5	-13.4 – 4.4

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 Secondary · Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported

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

Group	Value	95% CI
Motivational Interview and Text Messages	0.28	-0.07 – 0.63

Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Pain Score Secondary · Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported

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

Group	Value	95% CI
Motivational Interview and Text Messages	-0.13	-0.47 – 0.20

Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Objectively Measured Step Count Secondary · Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported

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

Group	Value	95% CI
Motivational Interview and Text Messages	45.6	-311.6 – 402.9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.