Evaluation of SLEEP Program

Sleep Education for Elders Program Evaluation

This study tests the effectiveness of a new educational intervention designed to improve sleep outcomes among an older adult population.

Study Overview

• Status: Recruiting
• Conditions: Sleep
• Intervention / Treatment: Behavioral: SLEEP program

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robin Tucker, PhD; Phone Number: 5173533408; Email: TUCKER98@MSU.EDU

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Recruiting
      • Michigan State University
      • Contact: Robin Tucker, PhD; Phone Number: 517-353-3408; Email: TUCKER98@MSU.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• participants who choose to enroll in the SLEEP program

Exclusion Criteria:

• younger than 40 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Participants who participated in the SLEEP program.	Behavioral: SLEEP program; SLEEP is a 6-week educational program designed to improve sleep hygiene and habits.
No Intervention: Control; Participants who did not participate in the SLEEP program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality: Pittsburgh Sleep Quality Index	Change in sleep quality as measured by Pittsburgh Sleep Quality Index. Scores range from 0-21 with higher scores representing worse outcomes.	immediately after the program
Sleep quality: Pittsburgh Sleep Quality Index	Change in sleep quality as measured by Pittsburgh Sleep Quality Index. Scores range from 0-21 with higher scores representing worse outcomes.	Six months after program completion
Sleep duration	Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index	immediately after the program
Sleep duration	Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index	Six months after program completion
Daytime sleepiness	Change in daytime sleepiness measured by Epworth Sleepiness Scale. Scale scoring ranges from 0-24, with higher scores indicating worse outcomes.	immediately after the program
Daytime sleepiness	Change in daytime sleepiness measured by Epworth Sleepiness Scale. Scale scoring ranges from 0-24, with higher scores indicating worse outcomes.	Six months after program completion
Insomnia symptoms	As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.	immediately after the program and six months later
Insomnia symptoms	As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.	Six months after program completion
Sleep hygiene habits	As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.	immediately after the program
Sleep hygiene habits	As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.	Six months after program completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep-related knowledge	As measured by several questions related to sleep health and hygiene	immediately after the program
Sleep-related knowledge	As measured by several questions related to sleep health and hygiene	six months later
Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration	As measured by questions measuring personal satisfaction with sleep quality and duration	immediately after the program
Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration	As measured by questions measuring personal satisfaction with sleep quality and duration	six months later
Program satisfaction: questions and comments related to program experiences	As measured by questions and comments related to program experiences	immediately after the program
Program satisfaction: questions and comments related to program experiences	As measured by questions and comments related to program experiences	six months later

Collaborators and Investigators

• Sponsor: Michigan State University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00003748

Drug and device information, study documents

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