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Mobile Motivational Physical Activity Targeted Intervention (MobMPATI)

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivaltional interviews and infrequent motivational text messages
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring mobile, sleep, physical activity, older adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Motivational interview and text messages

Arm Description

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

Outcomes

Primary Outcome Measures

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 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

Secondary Outcome Measures

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 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 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

Full Information

First Posted
April 20, 2017
Last Updated
April 21, 2023
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03160287
Brief Title
Mobile Motivational Physical Activity Targeted Intervention
Acronym
MobMPATI
Official Title
Mobile Motivational Physical Activity Targeted Intervention (MobMPATI) to Improve Sleep in Older Adults With Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
mobile, sleep, physical activity, older adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational interview and text messages
Arm Type
Experimental
Arm Description
Multidimensional, tailored intervention for sleep deficiency in for older adults with OA
Intervention Type
Behavioral
Intervention Name(s)
Motivaltional interviews and infrequent motivational text messages
Intervention Description
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 Outcome Measure Information:
Title
Mixed Effect Model Inferential Estimates of Longitudinal Changes Across 3 Time Points (Baseline, Week 14, Week 19) in Insomnia Severity Index
Description
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
Title
Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time Points (Baseline, Week 14, Week 19) in Actigraphy Total Sleep Time (TST)
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Pain Score
Description
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
Title
Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time-points (Baseline, Week 14, Week 19) in Objectively Measured Step Count
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oleg Zaslavsky
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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Mobile Motivational Physical Activity Targeted Intervention

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