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Self-Management of Sleep Among Older Adults

Primary Purpose

Sleep Disturbance

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Personal Sleep Monitoring
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Disturbance focused on measuring Older People, Sleep Disturbance, Self-Monitoring, Self-Management, Social Support, Wrist-worn Actigraphy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Massachusetts

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Passive Personal Sleep Monitoring

Individual Personal Sleep Monitoring

Socially Supported Sleep Monitoring

Arm Description

Wears personal sleep monitor but does not actively self-monitor (will have access to the sleep data and self-monitoring after 4 weeks).

Wears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep.

Wears a personal sleep monitor, actively self-monitoring using sleep data to self-manage sleep and shares data for supportive self-management.

Outcomes

Primary Outcome Measures

Use of A Personal Sleep Monitoring Device (PSMD)
Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report
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.
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)

Secondary Outcome Measures

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

Full Information

First Posted
January 24, 2019
Last Updated
February 24, 2020
Sponsor
University of Massachusetts, Amherst
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1. Study Identification

Unique Protocol Identification Number
NCT03837249
Brief Title
Self-Management of Sleep Among Older Adults
Official Title
Self-Management of Sleep Among Older Adults Using Personal Monitoring: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Amherst

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance
Keywords
Older People, Sleep Disturbance, Self-Monitoring, Self-Management, Social Support, Wrist-worn Actigraphy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Comparative control - 3 group
Masking
Participant
Masking Description
One group - personal sleep monitoring data with-held then provided after the intervention period.
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive Personal Sleep Monitoring
Arm Type
Placebo Comparator
Arm Description
Wears personal sleep monitor but does not actively self-monitor (will have access to the sleep data and self-monitoring after 4 weeks).
Arm Title
Individual Personal Sleep Monitoring
Arm Type
Active Comparator
Arm Description
Wears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep.
Arm Title
Socially Supported Sleep Monitoring
Arm Type
Active Comparator
Arm Description
Wears a personal sleep monitor, actively self-monitoring using sleep data to self-manage sleep and shares data for supportive self-management.
Intervention Type
Device
Intervention Name(s)
Personal Sleep Monitoring
Other Intervention Name(s)
Personal Sleep Monitor
Intervention Description
Wearable Sleep Self-Monitoring Device (Actigraphy)
Primary Outcome Measure Information:
Title
Use of A Personal Sleep Monitoring Device (PSMD)
Description
Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report
Time Frame
up to 4 weeks
Title
Changes in Sleep
Description
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.
Time Frame
Week 1 and Week 4
Title
Changes in Health
Description
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)
Time Frame
Week 1 and Week 4
Secondary Outcome Measure Information:
Title
Usability of PSMD
Description
Demonstrated through adapted System Usability Scale Scores (10 items, 5 point likert scale) with high agreement demonstrating higher levels of satisfaction using the device
Time Frame
Week 2 and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raeann G LeBlanc, PhD, DNP
Organizational Affiliation
University of Massachusetts, Amherst
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD data will be shared de-identified as a GUID with the cdRNS data base.

Learn more about this trial

Self-Management of Sleep Among Older Adults

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