NCT05621265

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

November 10, 2022

Last Update Submit

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

EXPERIMENTAL

Automated Text messaging for sleep behavior change

Behavioral: Automated Text messaging

Control

NO INTERVENTION

Control, Traditional physical therapy only

Interventions

daily text message

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Ashley Pfeiffer, DPT

    Black Hills State University

    PRINCIPAL INVESTIGATOR

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

Will share all data from excel.

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

Locations