Continous Positive Airway Pressure (CPAP) Compliance Study

NCT01642160 | Completed

• 1 other identifier: 11-008195
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Does an internet based text or email interaction and education improve CPAP compliance for patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• change in mean number of nursing interventions at one month

  baseline to one month after initiation

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Participants randomized to this arm will have the usual follow up care without any additional information.

Behavioral: Standard of care

Additional Education

ACTIVE COMPARATOR

This arm will receive a weekly text message or e-mail asking participants to sign on to the web page that we will provide. Once they sign on, they will see additional educational materials and questions regarding their CPAP use. Based on their response, they will be directed to suggestion or sites to help improve their compliance with their CPAP.

Behavioral: additional educational material

Interventions

additional educational material BEHAVIORAL

The internet-based intervention group would receive a weekly text or an email (based on the subject's preference). The content of the message asks about their approximate compliance over the past week. Based on their response, they will be directed to one of two internet web pages.

Additional Education

Standard of care BEHAVIORAL

participants will receive education from staff nurses as needed.

Standard of care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age 18 - 90 years of age) newly diagnosed with OSA who have been recommended CPAP therapy.

You may not qualify if:

• Previously attempted CPAP, requires the use of bilevel positive airway pressure device, difficulty with English language such that they have difficulty understanding instructions given at high school equivalent, periodic limb movement associated arousals greater than 20/hour, primary complaint of insomnia, diagnosis of restless leg syndrome or periodic limb movement disorder

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• John Park, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

US (1)