Mobile Motivational Physical Activity Targeted Intervention

NCT03160287 | Completed Results

• 1 other identifier: 52062
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 1.Test the acceptability of MobMPATI for older adults with OA and poor sleep quality as a manifestation of sleep deficiency.
2. 2.Test the feasibility of implementing MobMPATI for older adults with OA, as well as collecting electronic data from the sample.
3. 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.

Conditions

Osteoarthritis

Keywords

mobile, sleep, physical activity, older adults

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

  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

  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

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

Study Arms (1)

Motivational interview and text messages

EXPERIMENTAL

Multidimensional, tailored intervention for sleep deficiency in for older adults with OA

Behavioral: Motivaltional interviews and infrequent motivational text messages

Interventions

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

Motivational interview and text messages

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Results Point of Contact

• Title: Oleg Zaslavsky
• Organization: University of Washington

ozasl@uw.edu

2066163242

Study Officials

• Oleg Zaslavsky

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 19, 2017
• Study Start: June 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: September 30, 2018
• Last Updated: April 25, 2023
• Results First Posted: May 21, 2021

Record last verified: 2023-04

Locations

US (1)