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A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints

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ClinicalTrials.gov Identifier: NCT03921840
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
It is well recognized that physical activity/exercise is an effective intervention to improve sleep, reduce pain and improve function in a variety of pain conditions. Traditional interventions to increase physical activity are challenging in older adults due to extensive staffing requirements and low adherence. The investigators plan to conduct a pilot trial in a cohort of older adults (without dementia) with both chronic musculoskeletal pain and nocturnal sleep complaints to test the effectiveness of a 12-week personalized behavioral intervention (compared to a control group) embedded within a smartwatch application in older adults. 20 cognitively intact elders will be enrolled and randomly allocated to intervention or control group. Participants in the intervention arm will receive a 2-hour in person education session, and personalized, circadian-based activity guidelines, with real time physical activity self-monitoring, interactive prompts, biweekly phone consultation with the research team, and financial incentives for achieving weekly physical activity goal. The control group will receive general education on physical activity in older adults and continue routine daily activity for 12 weeks.

Condition or disease Intervention/treatment Phase
Sleep Pain Behavioral: ELDERFITNESS Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Intervention
Based on the self-efficacy theory, participants in the intervention arm will receive personalized, circadian-based activity guidelines, a 2-hour in person education session, real time physical activity self-monitoring, interactive prompts, biweekly phone consultation with the research team, and financial incentives for achieving weekly physical activity goal.
Behavioral: ELDERFITNESS

In person training: Participants will receive a 2-hour in person education session with the exercise trainer. Self-monitoring: Subjects will self-monitor subjects' level of physical activity (steps & minutes of moderate activity) using the smartwatch. The Google calendar and Fitbit apps will send messages and alerts to the subject's smartwatch that encourage subjects to achieve subjects' daily goals. If a participant has low activity for 3 consecutive days, the research assistant will call the participant to either encourage the participant to adhere to the plan or provide a modified plan after consulting the exercise trainer.

Phone consultation: Subjects will have biweekly phone consultation with the research team members to receive guidance and adjustment on activity plans. Financial incentives: The intervention will include financial incentives. Specifically, when the daily activity goal is achieved for more than four days per week, a $5 reward will be given to subjects.


Placebo Comparator: Control
The control group will receive general education on physical activity for older adults and continue daily activity and healthcare routine. Participants will also receive a Go4Life program book from the National Institute on Aging.
Other: Control
General education on physical activity for older adults and continue daily activity and healthcare routine. Participants will also receive a Go4Life program book from the National Institute on Aging.




Primary Outcome Measures :
  1. Change in Objective Sleep Duration [ Time Frame: Week 1, Week 14 ]
    Total sleep time (minutes) will be measured using actigraph

  2. Change in Sleep Efficiency as assessed by actigraphy [ Time Frame: Week 1, Week 14 ]
    Sleep efficiency (reported as a percentage)will be measured using actigraph

  3. Change in Subjective Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week 1, Week 14 ]
    The PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

  4. Change in Pain Intensity as assessed by Visual analog pain scale [ Time Frame: Week 1, Week 14 ]
    Visual analog pain scale is a commonly used tool for pain intensity in research and clinical practice. It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable".

  5. Change in Pain Severity as assessed by the Brief Pain Inventory [ Time Frame: Week 1, Week 14 ]
    Brief Pain Inventory (BPI) rapidly assesses the severity of pain and has been commonly used in research studies. The BPI assesses pain at its "worst," "least," "average," and "now" (current pain). The average score of the all pain items will be used. The score ranges from 0 to 10.


Secondary Outcome Measures :
  1. Change in Fatigue as assessed by the FACIT Fatigue Scale [ Time Frame: Week 1, Week 14 ]
    The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The composite score of all item will be used. the total score ranges from 0 to 52. High scores represent less fatigue.

  2. Change in Self-reported well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 [ Time Frame: Week 1, Week 14 ]
    The PROMIS-29 measures self-reported physical, mental wellbeing. It consists of 29 questions. The questions are ranked on a 5-point Likert Scale. PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured.



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Intact cognition
  • Poor sleep quality
  • Self-reported presence of pain
  • Capacity for mild to moderate physical activity.

Exclusion Criteria:

  • Non-ambulatory or have severely impaired mobility,
  • Visual or hearing impairment that interfered with assessments, and
  • An acute or a terminal illness
  • Neuropathic pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921840


Contacts
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Contact: Junxin Li, PhD 410-502-2608 junxin.li@jhu.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Junxin Li, PhD    410-502-2608    junxin.li@jhu.edu   
Principal Investigator: Junxin Li, PhD         
Sub-Investigator: Sarah Szanton, PhD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Junxin Li, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03921840     History of Changes
Other Study ID Numbers: IRB00205661
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms