Self-Management of Sleep Among Older Adults

Self-Management of Sleep Among Older Adults Using Personal Monitoring: A Feasibility Study

The purpose of this study is to test the feasibility of older persons use of a personal sleep monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to 50% of persons over the age of 65 with chronic health conditions. Impaired sleep negatively influences subjective and objective health outcomes.To improve their sleep, older adults with chronic health conditions could benefit from objective information, available through personal health monitoring devices, about their current and changing sleep patterns. Based on this information, sleep self-management interventions can be individualized and shared, and associations between sleep and health changes may be better managed.

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance
• Intervention / Treatment: Device: Personal Sleep Monitoring

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01003
      • University of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 65 years or older
• Self-report difficulty sleeping
• Willingness to wear the PSMD for four weeks
• Cognitive abilities (Mini Cog of 5 or above).

Exclusion Criteria:

• Under the age of 65
• Presence of known sleep disorders
• Severe cognitive or neurosensory impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Passive Personal Sleep Monitoring; Wears personal sleep monitor but does not actively self-monitor (will have access to the sleep data and self-monitoring after 4 weeks).	Device: Personal Sleep Monitoring; Wearable Sleep Self-Monitoring Device (Actigraphy); Other Names: Personal Sleep Monitor
Active Comparator: Individual Personal Sleep Monitoring; Wears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep.	Device: Personal Sleep Monitoring; Wearable Sleep Self-Monitoring Device (Actigraphy); Other Names: Personal Sleep Monitor
Active Comparator: Socially Supported Sleep Monitoring; Wears a personal sleep monitor, actively self-monitoring using sleep data to self-manage sleep and shares data for supportive self-management.	Device: Personal Sleep Monitoring; Wearable Sleep Self-Monitoring Device (Actigraphy); Other Names: Personal Sleep Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of A Personal Sleep Monitoring Device (PSMD)	Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report	up to 4 weeks
Changes in Sleep	Demonstrated sleep changes indicated by change in BRCS NINR PROMIS SF V1 Sleep Disturbance Scale 6a (a 6 item, 5 point likert scale with higher scores reflecting more sleep disturbance and lower scores less.	Week 1 and Week 4
Changes in Health	Demonstrated health changes indicated by change in BRCS NINR PROMIS Global Health Short Form Scale 10a (10 item, 5 point likert scale) with higher scores reflecting better health (3 items reverse scoring)	Week 1 and Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of PSMD	Demonstrated through adapted System Usability Scale Scores (10 items, 5 point likert scale) with high agreement demonstrating higher levels of satisfaction using the device	Week 2 and 4

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst
• Investigators: Principal Investigator: Raeann G LeBlanc, PhD, DNP, University of Massachusetts, Amherst

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Self-Monitoring; Self-Management; Social Support; Sleep Disturbance; Older People; Wrist-worn Actigraphy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 2018-5225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD data will be shared de-identified as a GUID with the cdRNS data base.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No