Efficacy of Automated Text Messaging Services

Efficacy of Automated Text Messaging Services on Sleep Health, Stress, Pain, and Function in Physical Therapy Patients

The goal of this clinical trial is to test automated text messaging as an effective behavior change intervention in physical therapy patients. The main purpose of this study was to trial sleep hygiene education for improving physical therapy patients' sleep through the use of daily automated text messaging. Researchers will compare two groups to see if the intervention group which consisted of participants getting daily automated text messages for sleep hygiene tips would be effective in improving sleep, health, pain, and function compared to a group that is receiving traditional physical therapy alone.

Study Overview

• Status: Completed
• Conditions: Sleep; Physical Therapy
• Intervention / Treatment: Behavioral: Automated Text messaging

Detailed Description

Participants will be recruited from the outpatient physical therapy clinic verbally by their therapist and by an informational handout they receive from the therapist. The student researcher (who also works at this clinic) will then contact the participant to set up a time to complete the initial survey questions at the clinic in a private treatment room. During the initial visit, participants will read through and sign informed consent explaining the procedures and expectations of them during the study. The participants will then complete the following questionnaires: Pittsburgh Sleep Quality Index, Sleep Hygiene Index, Medical Outcome Survey-sleep 9, Perceived Stress Scale, Numeric Pain Rating Scale, and Patient Specific Functional Scale. The participants will randomly be assigned to one of two groups. The intervention group will receive daily automated text messages scheduled for 8:00 pm every evening. The text messages will include a variety of sleep hygiene behavioral tips for the participant to try. This will last for a total of four weeks. The control group will not receive any intervention during this time frame. Following the four weeks, student researchers will return to each participant's clinic to collect the same data that was collected at the initial visit. Each participant will have a total of 2 sessions to complete with each session taking approximately 15-30 minutes to complete.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Spearfish, South Dakota, United States, 57799
      • Black Hills Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Adults 18 years and older seeking outpatient Physical Therapy

Exclusion Criteria:

Inability to access a smart-phone or computer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Automated Text messaging for sleep behavior change	Behavioral: Automated Text messaging; daily text message
NO_INTERVENTION: Control; Control, Traditional physical therapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	sleep quality measurement. Scores range 0-21 with higher score indicating poorer sleep quality.	initial visit and 4-week follow up
Sleep Hygiene Index	measuring participants sleep hygiene behaviors. Scores range 0-52 with a higher score indicating poorer sleep hygiene.	initial and 4-week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale	stress measurement. Scores range 0-40 with higher score indicating greater stress.	initial and 4-week follow up
Patient Specific Functional Scale	scale for improving patient's top three chosen functions they want to improve. Scores range from 0-10 with lower scores indicating poorer function.	initial and 4-week follow up
Numeric Pain rating Scale	tool to measure pain. 0-10 with 10 being highest pain possible.	Initial and 4-week follow up

Collaborators and Investigators

• Sponsor: Black Hills State University
• Investigators: Principal Investigator: Ashley Pfeiffer, DPT, Black Hills State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2021
• Primary Completion (ACTUAL): April 1, 2022
• Study Completion (ACTUAL): May 1, 2022

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (ACTUAL): November 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BlackHillsSTATE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will share all data from excel.
• IPD Sharing Time Frame: Data is available now for anyone who is interested.
• IPD Sharing Access Criteria: Data will be available by request through emailing the PI Ashley Pfeiffer at ashley.pfeiffer@bhsu.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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