A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints
Primary Purpose
Sleep, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ELDERFITNESS
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Sleep
Eligibility 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
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Objective Sleep Duration
Total sleep time (minutes) will be measured using actigraph
Change in Sleep Efficiency as Assessed by Actigraphy
Sleep efficiency (reported as a percentage)will be measured using actigraph
Secondary Outcome Measures
Full Information
NCT ID
NCT03921840
First Posted
April 2, 2019
Last Updated
October 7, 2022
Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT03921840
Brief Title
A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints
Official Title
A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
September 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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. 27 cognitively intact elders were enrolled and randomly allocated to intervention or control group. Participants in the intervention arm received 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 received general education on physical activity in older adults and continue routine daily activity for 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ELDERFITNESS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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 Measure Information:
Title
Change in Objective Sleep Duration
Description
Total sleep time (minutes) will be measured using actigraph
Time Frame
Week 1, Week 14
Title
Change in Sleep Efficiency as Assessed by Actigraphy
Description
Sleep efficiency (reported as a percentage)will be measured using actigraph
Time Frame
Week 1, Week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junxin Li, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints
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