Obesity, Obstructive Sleep Apnea
Conditions
Brief summary
The purpose of this study is to develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life.
Interventions
BEHAVIORALHome-based pulmonary rehabilitation (PR) system
Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors upload the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches call patients regularly to celebrate progress, assist with any issues, and set new goals.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Minnesota HealthSolutions
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, 18 years of age or older. * Diagnosis of Obstructive Sleep Apnea (OSA) and obesity (BMI \> or = to 35).
Exclusion criteria
* Individuals \< 18 years of age. * Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Use the Devices at Home | 2 Weeks | The number of participants who were able to utilize the devices at home. |
| Usability of Proposed System in Patients With OSA and Obesity | 2 Weeks | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the ease of using the technology on a scale of 1 to 10 (1=very difficult, 10=very easy), with higher scores indicating a better outcome. |
| Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity | 2 Weeks | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the helpfulness of the setup instructions from 1 to 10 (1=not at all helpful, 10=very helpful), with lower scores indicating a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity | 2 Weeks | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their confidence in using the proposed system greater than a 6 on a 10-point scale. The scale ranged from 1=not confident to 10=very confident, with higher scores indicating greater confidence. |
| Perceived Benefit of Proposed System in Patients With OSA and Obesity | 2 Weeks | Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their perceived benefit from the system greater than a 7 on a 10-point scale. The scale ranged from 1=not beneficial to 10=very beneficial, with higher scores indicating greater benefit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Severe Comorbid OSA Newly-diagnosed severe comorbid obstructive sleep apnea subjects used technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system
Home-based pulmonary rehabilitation (PR) system: Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors uploaded the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches called patients regularly to celebrate progress, assist with any issues, and set new goals. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Severe Comorbid OSA |
|---|---|
| Age, Continuous | 54.76 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Ability to Use the Devices at Home
The number of participants who were able to utilize the devices at home.
Time frame: 2 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Severe Comorbid OSA | Ability to Use the Devices at Home | 15 Participants |
Primary
Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity
Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the helpfulness of the setup instructions from 1 to 10 (1=not at all helpful, 10=very helpful), with lower scores indicating a worse outcome.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Severe Comorbid OSA | Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity | 9.2 score on a scale |
Primary
Usability of Proposed System in Patients With OSA and Obesity
Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the ease of using the technology on a scale of 1 to 10 (1=very difficult, 10=very easy), with higher scores indicating a better outcome.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Severe Comorbid OSA | Usability of Proposed System in Patients With OSA and Obesity | 9.5 score on a scale |
Secondary
Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity
Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their confidence in using the proposed system greater than a 6 on a 10-point scale. The scale ranged from 1=not confident to 10=very confident, with higher scores indicating greater confidence.
Time frame: 2 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Severe Comorbid OSA | Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity | 15 Participants |
Secondary
Perceived Benefit of Proposed System in Patients With OSA and Obesity
Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their perceived benefit from the system greater than a 7 on a 10-point scale. The scale ranged from 1=not beneficial to 10=very beneficial, with higher scores indicating greater benefit.
Time frame: 2 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Severe Comorbid OSA | Perceived Benefit of Proposed System in Patients With OSA and Obesity | 15 Participants |