Personalized Approach To Habits - Sleep (PATH-S)

KDH Research & Communication

Status: Enrolling

Conditions: Habits; Attitude; Asthma in Children; Sleep Disturbance; Knowledge, Attitudes, Practice; Adolescent Behavior

Treatments: Behavioral: PATH-S app

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT07029919

2025-02-02

1R43HL174208-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Two arm study, intervention and control, to explore the impact of an app to help high risk teens with asthma improve their sleep

Full description

The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the Personalized Approach To Habits - Sleep (PATH-S app) and explore the following research question: To what extent does exposure to the PATH-S app increase teens' knowledge, cues to action, perceived sleepiness, and self-efficacy related to improving sleep?

PATH-S will use casual gaming and intermittent reinforcement techniques to encourage teens to adopt and persist with personalized habits to improve sleep duration. Researchers worked with subject matter experts, physicians, and the intended audience to ensure the PATH-S app reflects the specific needs of high risk teens with asthma; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for teens to improve their overall sleep and habits.

The Principal Investigator (PI), with input from the subject matter experts and physicians, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents were reviewed by the KDH Research & Communication (KDHRC) Institutional Review Board before the evaluation launch.

Investigators will recruit participants through evaluation partners who will disseminate the study information to teens via electronic notifications and flyers. Evaluation partners include national asthma organizations. The notifications and flyers provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.

After consent and enrollment into the study, teens will complete a pretest survey and be randomly assigned to the intervention or control group. The intervention group will be exposed to the PATH-S app, with educational material, and will complete an online posttest survey after 28 days. The control group participants will be exposed to a cloned copy of the PATH-S app, but without the educational material, and will complete an online posttest survey after 28 days. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.

The investigators will download and export the data from Alchemer, along with data logged on the app, into encrypted Excel files and import the raw data into STATA. The investigators will match the pretest and posttest responses using the non-personal identifiers and conduct analyses to test for the effect of the PATH-S app exposure on changes in teens' knowledge, cues to action, perceived sleepiness, and self-efficacy related to improving sleep.

The initial feasibility criterion is: Statistically significant (p<0.05) and positive relationship between exposure to PATH-S app and increased knowledge among the intervention group in comparison to the control group.

Enrollment: 120 estimated patients

Sex: All

Ages: 14 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be between 14 and 17 years old.
• Have an asthma diagnosis from a healthcare provider.
• Speak and understand English.
• Have access to a computer and the Internet.
• Have a smartphone and the ability to download and use an app.
• Live in the United States.

Exclusion criteria

• None

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

PATH-S Treatment

Experimental group

Description:

Teens in the treatment group will be exposed to the educational material on the PATH-S app. They will engage with the app, log daily habits and sleep, and complete pretest and posttest assessments to measure changes in their knowledge, attitudes, intentions and self-efficacy.

Treatment:

Behavioral: PATH-S app

Control

No Intervention group

Description:

Teens in the control group will not be exposed to the educational material on the PATH-S app. They will engage with the app, continue their usual schedules without the additional educational material, and complete pretest and posttest assessments to measure changes in their knowledge, attitudes, intentions and self-efficacy.