Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)
Part of paid clinical trials in Overland Park, Kansas.
- Sponsor
- Kansas City Heart Rhythm Research Foundation
- Study ID
- NCT06672861
- Status
- Not Yet Recruiting
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Conditions
- Cardiac Dysautonomia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) — OTHERTo compare in patients with cardiac dysautonomia, newly developed disease specific questionnaire to established generalized SF-36 and EQ-5d questionnaires, as there are no disease specific questionnaires for comparison. These novel and established questionnaires will then be compared among groups who have relatively stable disease or stable symptoms with patients who will be expected to have a change in symptoms and QoL.
Study Details
Main aim will be to compare in patients with cardiac dysautonomia, newly developed disease specific questionnaire to established generalized SF-36 and EQ-5d questionnaires, as there are no disease specific questionnaires for comparison. These novel and established questionnaires will then be compared among groups who have relatively stable disease or stable symptoms with patients who will be expected to have a change in symptoms and QoL.
Key Dates
- Start date
- Jan 31, 2026
- Status verified
- Nov 2024
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Other: Newly diagnosed/untreated/incompletely treated for Cardiac Dysautonomia PatientsNewly diagnosed/untreated/incompletely treated for Cardiac Dysautonomia (Postural Orthostatic Tachycardia Syndrome (POTS), Inappropriate Sinus Tachycardia (IST), and Vasovagal syncope (VVS)) Patients
- Other: Previously diagnosed/treated/undergone sinus node modification for Cardiac Dysautonomia PatientsPreviously diagnosed/treated/previously undergone sinus node modification for Cardiac Dysautonomia Patients (Postural Orthostatic Tachycardia Syndrome (POTS), Inappropriate Sinus Tachycardia (IST), and Vasovagal syncope (VVS)) Patients
Primary Outcome Measure
To develop and validate KCDysQ as a quality of life and symptom severity assessment tool [ Time Frame: 3 Months ]
Central Contacts
- Donita Atkins816-651-1969
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Kansas City Heart Rhythm Institute | Overland Park | Kansas | 66211 | - |
| Midwest Heart and Vascular Specialists | Overland Park | Kansas | 66211 | - |
| Overland Park Regional Medical Center | Overland Park | Kansas | 66215 | - |