OsteoarthritisMobMPATINCT03160287
Mobile Motivational Physical Activity Targeted Intervention
A study testing Motivaltional interviews and infrequent motivational text messages in people with Osteoarthritis, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Motivaltional interviews and infrequent motivational text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Motivational Physical Activity Targeted Intervention (MobMPATI) to Improve Sleep in Older Adults With Osteoarthritis
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:
Read more
- 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.
- Conditions
- Osteoarthritis
- Being tested
- Motivaltional interviews and infrequent motivational text messages
- Keywords
- mobile, sleep, physical activity, older adults
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivaltional interviews and infrequent motivational text messagesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Motivational interview and text messages | Experimental | Multidimensional, tailored intervention for sleep deficiency in for older adults with OA Receives: Behavioral: Motivaltional interviews and infrequent motivational text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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
Measured: 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
Measured: 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
Measured: Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Jun 2017
- Primary completion31 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oleg Zaslavsky, University of Washington
- Investigators
- Oleg Zaslavsky, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160287
- Sponsor's protocol ID
- 52062
- Acronym
- MobMPATI
- Status last verified
- Apr 2023
- First submitted
- 20 Apr 2017
- Last updated
- 25 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Motivational Physical Activity Targeted Intervention (MobMPATI) to Improve Sleep in Older Adults With Osteoarthritis
- ClinicalTrials.gov ID
- NCT03160287
- Acronym / sponsor ID
- MobMPATI / 52062
- Conditions
- Osteoarthritis
- Keywords
- mobile, sleep, physical activity, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 21 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motivational interview and text messages | Experimental | Behavioral: Motivaltional interviews and infrequent motivational text messagesMultidimensional, tailored intervention for sleep deficiency in for older adults with OA |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- >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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivaltional interviews and infrequent motivational text messagesA 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 | Behavioural | Motivational interview and text messages |
Primary outcome
Mixed Effect Model Inferential Estimates of Longitudinal Changes Across 3 Time Points (Baseline, Week 14, Week 19) in Insomnia Severity Index
Time frame: 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
Mixed Effect Model Inferential Estimates of Longitudinal Changes Across Three Time Points (Baseline, Week 14, Week 19) in Actigraphy Total Sleep Time (TST)
Time frame: 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
3 secondary outcomes
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
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
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
Time frame: Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oleg Zaslavsky principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivaltional interviews and infrequent motivational text messages in people with Osteoarthritis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mixed Effect Model Inferential Estimates of Longitudinal Changes Across 3 Time Points (Baseline, Week 14, Week 19) in Insomnia Severity Index (time frame: Assessed at Baseline, week 14, week 19; change from baseline throughout three time points reported). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.