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
|Condition or disease||Intervention/treatment||Phase|
|Sleep Pain||Behavioral: ELDERFITNESS Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
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.
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.
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.
- Change in Objective Sleep Duration [ Time Frame: Week 1, Week 14 ]Total sleep time (minutes) will be measured using actigraph
- 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
- 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.
- 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".
- 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.
- 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.
- 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.
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
|Contact: Junxin Li, PhDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Junxin Li, PhD 410-502-2608 email@example.com|
|Principal Investigator: Junxin Li, PhD|
|Sub-Investigator: Sarah Szanton, PhD|
|Principal Investigator:||Junxin Li, PhD||Johns Hopkins University|