Johns Hopkins University
Baltimore, Maryland, 21287, United States
NCT Number: NCT05400837
The overall objective of this proposal is to evaluate the feasibility of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.
Researchers plan to evaluate the feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21287, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention aims to implement guideline-recommended Afib care
Time frame: 12 weeks
Feasibility assessed by retention at 12 weeks (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion)
Time frame: 12 weeks
Measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT), which consists of 20 items. Score ranges from 0 to 100 with higher scores signifying better quality of life.
Time frame: 12 weeks
Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire. Includes 5 subscores. AF burden is the sum of AF duration, AF severity, and AF frequency, and ranges from 3 to 30, with 30 being highest burden. AF duration, severity, and frequency each range from 1 to 10. The final subscore is AF symptoms, which ranges from 0-35 with 35 indicating worst possible symptoms.
Time frame: 12 weeks
Measured by 8-item questionnaire eHealth Literacy Scale. Scores range from 10-50 with a higher score indicating higher electronic health literacy.
Time frame: 12 weeks
Measured by Patient Health Questionnaire 8 (PHQ - 8) - 8-item measure with (≤4: no depressive symptom, 5-9: mild, ≥10: moderate to severe depressive symptoms). Score range 0-27 with higher score indicating more depressive symptoms.
Time frame: 12 weeks
Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety.
Time frame: 12 weeks
Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress.
Time frame: 12 weeks
Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA). Part 1 scores range from 1-5 with increasing scores indicating higher levels of activity, 5 being optimal. Part 2 is scored from 0-3 and measures the amount of flexibility and calisthenics exercise a person completes, with 3 being optimal.
Time frame: 12 weeks
As assessed by The Alcohol Use Disorders Identification Test (AUDIT), 10-item questionnaire. The score range is from 0 to 40 with 0 referring to abstainer with no history of alcohol abuse and higher scores indicate gradually higher and hazardous alcohol dependence.
Time frame: 12 weeks
Measured by Rate Your Plate (RYP) scale. A 27 item scale administered at 12 weeks with the following scoring system: Score ranges from 27-81.
Score of 27-45: There are many ways you can make your eating habits healthier. 46-63: There are some ways you can make your eating habits healthier. 64-81: Higher score indicates participant is making many healthy choices.
Time frame: 12 weeks
Measured in millimeters of mercury (mmHg).
Time frame: 12 weeks
Measured in kilograms over meter squared (Kg/m^2).
Time frame: 12 weeks
Measured by the System Usability Scale (SUS), modified for the intervention. The SUS score ranges from 0-100, where 0 is "worst imaginable" and 100 is "best imaginable." The average score is 68.0, a good score is between 71.4-85.4. 85.5 and above is considered excellent. Higher score more satisfaction.
Time frame: Studies were completed one time between enrollment and end of treatment at 12 weeks
Patients completed an at-home sleep study and received a diagnosis of no sleep apnea, mild sleep apnea, moderate sleep apnea, or severe sleep apnea, based on their AHI (apnea-hypopnea index). AHI is measured in breathing disturbance events per hour. An AHI <5 indicates no sleep apnea, from 5-15 is mild, 16-30 is moderate, and >30 is severe sleep apnea.
Johns Hopkins University
Other
Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial
Acronym: mTECHAFib
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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