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Adherence to Health Coaching with Wearable Devices: Enhancing Patient Engagement and Outcomes

NCT06525337 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-09

No results posted yet for this study

Summary

The goal of this clinical trial is to learn how integrating health and wellness coaching (HWC) with Continuous Positive Airway Pressure (CPAP) therapy affects adherence to treatment and overall health outcomes in individuals with obstructive sleep apnea. The main questions it aims to answer are:

* Does HWC improve CPAP adherence compared to standard care, in terms of device usage metrics (hours per night and days per month)?
* How does combining HWC with weight management influence CPAP adherence and weight loss?
* What are the differences in treatment outcomes between individuals receiving standard care and those receiving HWC?

Researchers will compare two groups:

* Standard Care Group: Participants receiving standard CPAP therapy without additional health coaching.
* HWC Group: Participants receiving CPAP therapy combined with health and wellness coaching focused on weight management and sleep hygiene.

Participants will:

* Attend 2 in-office visits with a study physician (2 hours maximum)
* Have 6 virtual visits via video with a study health coach (3 hours maximum) if in the HWC group This study aims to provide valuable insights into enhancing treatment outcomes for individuals with sleep apnea by integrating health coaching with CPAP therapy.

Conditions

Interventions

BEHAVIORAL

STANDARDCARE (STAND) group

Will receive a device and health coaching

OTHER

CONTROL (CON) group

Will not use any devices or receive health coaching

Sponsors & Collaborators

  • Apnimed

    collaborator INDUSTRY

  • inHealth Medical Services, Inc.

    collaborator INDUSTRY

  • Coastal Carolina University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2024-12-29
Completion
2025-03-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06525337 on ClinicalTrials.gov