Efficacy of Automated Text Messaging Services

Sponsor
Black Hills State University (Other)
Overall Status
Completed
CT.gov ID
NCT05621265
Collaborator
(none)
20
1
2
7
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Automated Text messaging
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy of Automated Text Messaging Services on Sleep Health, Stress, Pain, and Function in Physical Therapy Patients
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pittsburgh Sleep Quality Index [initial visit and 4-week follow up]

    sleep quality measurement. Scores range 0-21 with higher score indicating poorer sleep quality.

  2. Sleep Hygiene Index [initial and 4-week follow up]

    measuring participants sleep hygiene behaviors. Scores range 0-52 with a higher score indicating poorer sleep hygiene.

Secondary Outcome Measures

  1. Perceived Stress Scale [initial and 4-week follow up]

    stress measurement. Scores range 0-40 with higher score indicating greater stress.

  2. Patient Specific Functional Scale [initial and 4-week follow up]

    scale for improving patient's top three chosen functions they want to improve. Scores range from 0-10 with lower scores indicating poorer function.

  3. Numeric Pain rating Scale [Initial and 4-week follow up]

    tool to measure pain. 0-10 with 10 being highest pain possible.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Adults 18 years and older seeking outpatient Physical Therapy

Exclusion Criteria:

Inability to access a smart-phone or computer

Contacts and Locations

Locations

Site City State Country Postal Code
1 Black Hills Physical Therapy Spearfish South Dakota United States 57799

Sponsors and Collaborators

  • Black Hills State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Black Hills State University
ClinicalTrials.gov Identifier:
NCT05621265
Other Study ID Numbers:
  • BlackHillsSTATE
First Posted:
Nov 18, 2022
Last Update Posted:
Nov 21, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 21, 2022