Efficacy of Automated Text Messaging Services
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedNovember 21, 2022
November 1, 2022
6 months
November 10, 2022
November 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Perceived Stress Scale
initial and 4-week follow up
Patient Specific Functional Scale
initial and 4-week follow up
Numeric Pain rating Scale
Initial and 4-week follow up
Study Arms (2)
Intervention
EXPERIMENTALAutomated Text messaging for sleep behavior change
Control
NO INTERVENTIONControl, Traditional physical therapy only
Interventions
Eligibility Criteria
You may qualify if:
- Adults 18 years and older seeking outpatient Physical Therapy
You may not qualify if:
- Inability to access a smart-phone or computer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Black Hills Physical Therapy
Spearfish, South Dakota, 57799, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ashley Pfeiffer, DPT
Black Hills State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2022
First Posted
November 18, 2022
Study Start
October 1, 2021
Primary Completion
April 1, 2022
Study Completion
May 1, 2022
Last Updated
November 21, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data is available now for anyone who is interested.
- Access Criteria
- Data will be available by request through emailing the PI Ashley Pfeiffer at ashley.pfeiffer@bhsu.edu
Will share all data from excel.