Motivational Enhancement - Acute Decompensated Heart Failure and OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

Effect of Post-Discharge Telemedicine Motivational Enhancement Intervention in Heart Failure and Obstructive Sleep Apnea on Adherence and Health Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752462
• Other study ID #: 21-075
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: Joan Aylor, BA
• Phone: 216-445-1698
• Email: aylorj[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A feasibility randomized controlled trial will be conducted with a 6-month follow up to: Examine the impact of early intensive telemedicine motivational enhancement (TIME) vs standard of care on PAP adherence (n=40/group) and continuity of care at 3 and 6 months post-discharge in patients admitted with ADHF with a new inpatient diagnosis of OSA(REI>5). Assess the effect of early telemedicine integrated with motivational enhancement (TIME) vs standard of care on patient reported outcomes including Functional Outcomes of Sleep questionnaire (FOSQ-10), Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Investigate the impact of early TIME vs standard of care on 6-month hospital readmissions.

Description:

As part of our inpatient sleep testing program, high-risk HF patients undergo Type III sleep testing (Nihon Kohden®) set up by sleep laboratory technicians. Our inpatient sleep service also has a clinical nurse who works with patients on CPAP education, set up and assists with post hospital sleep care. If a titration study is needed, it is generally arranged 1-2 weeks post discharge. All inpatient sleep studies are scored by three registered polysomnographic technologists and I review and finalize these studies (current clinical flow as the primary physician leading the inpatient service, which will be augmented for this clinical trial). A research coordinator and I will approach those with REI>5 who meet eligibility per screening in Epic®, to discuss sleep study results, confirm eligibility, invite the patient to participate, and if interested, will obtain written informed consent. Consent: Consent form will explain in a lay person' terminology the nature of all procedures. It will be stressed that participation is voluntary. The research coordinator and the PI will be available to answer questions. All activities will be compliant with local IRB and HIPPA guidelines.

All participants will obtain Auto-CPAP from two manufacturers (Philips Respironics ® or ResMed ®) delivered by the same homecare health before discharge. PAP pressures will be set at 5-15 cmH2O, heated humification, and expiratory pressure relief according to comfort. A modem will be attached to the PAP device to extract adherence data remotely (SD card for those without wireless capability). All patients will receive a standardized 20-minute educational session about PAP therapy before discharge and will be advised to use their device every night during sleep by our clinical nurse. Patients will also be fitted for a mask fitted homecare health. If participants have mask or pressure intolerance issues, they will be a direct provided a phone number to our research coordinator. All baseline questionnaires will be sent via REDcap link to the patient's e-mail or completed in paper form before discharge and during their visit (or paper if electronic not feasible). The coordinator will ensure all questionnaires are completed before discharge and will instruct patients to complete follow-up questionnaires. Patients will be randomized (REDCap algorithm) 1:1 to TIME versus standard of care. Blocks will be of random size blinded to study investigators. Although it will not be feasible to blind the research team and participants to the intervention, the standard of care group will also receive sleep hygiene education so that there is perception of some level of intervention to try to address placebo effect. During follow up visits (2 weeks and 2 months for the TIME group and 2 months standard of care group) with sleep medicine, the first 15 minutes will be focused on OSA and troubleshooting problems for both groups as this is standard clinical care provided at our Sleep Disorders Center. These 15 minutes will be followed by 30 minutes of ME in the intervention group and 10 minutes of sleep hygiene education in the control group. Outcomes will be measured at 3 months and 6 months for both groups. Both groups will receive a booster phone call at 4 months. The intervention group will receive a 30 minutes booster ME session and the control group will receive 10 minutes of sleep hygiene.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admitting ADHF diagnosis

• OSA diagnosis (REI =5)

• Treatment-naive and agreeable to PAP therapy

• Agrees to participate.

Exclusion Criteria:

• Prior or current PAP therapy

• Unable to provide informed consent

• Moderately hypoxic (oxygen saturation < 87% on room air or requiring >2L of O2 during overnight sleep study

• Hemodynamically unstable (systolic blood pressure, SBP<90 mmHg, heart rate>120bpm)

• Central predominant apnea (Central Apnea Index > 50% of the Apnea Index) Dementia/cognitive dysfunction

• Unable to participant in video televisits.

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure
• Motivational Enhancement
• Obstructive Sleep Apnea
• PAP Adherence
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Telemedicine Intensive Motivational Enhancement
Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	American Academy of Sleep Medicine

Country where clinical trial is conducted

United States, 

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of TIME vs Standard of Care on 6-month hospital readmissions	6-month hospital readmissions	6 Month
Primary	PAP Adherence (TIME versus Standard of Care)	average hourly use per night	3 Month
Primary	PAP Adherence (TIME versus Standard of Care)	average hourly use per night	6 Month
Primary	Functional Outcomes of Sleep Questionnaire (TIME versus Standard of Care)	Functional Outcomes of Sleep Questionnaire (FOSQ-10): Subscale scores range from 1-4 (1= extreme difficulty, 2= moderate difficulty, 3= a little difficulty, 4= no difficulty) with total scores ranging from 5-20 with higher scores indicating better functional status.	2 Months
Primary	Kansas City Cardiomyopathy Questionnaire (TIME versus Standard of Care)	Kansas City Cardiomyopathy Questionnaire (KCCQ-12):: physical limitation, symptom frequency, quality of life, and social limitation. Scores ranges from 5-30, higher KCCQ-12 scores from baseline represent better health status	2 Months