Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
The study is expected to provide evidence to support claim(s) that: * Education and process improvement initiatives can improve the diagnosis of and appropriate therapy application for sinus node dysfunction (SND) * The quality improvement methods studied have general applicability and can be used by all centers * Appropriate treatment minimizes caregiver burden * Appropriate treatment improves quality of life (QOL) and functional status compared to pre-implant
Study Type
OBSERVATIONAL
Enrollment
1,342
Education, guidelines, tools
Hospital General de Agudos
Buenos Aires, Argentina
National Heart Foundation Hospital and Research Institute
The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention
The absolute change in the proportion of subjects diagnosed with SND before and after intervention
Time frame: Up to 1 year post enrollment
The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention
Outcome measure applies to subjects that receive a SND diagnosis
Time frame: Up to 6 months post diagnosis
The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy
Enrolled subjects only with an SND diagnosis were reassessed at 6 and 12 months post enrollment were reassessed for IPG therapy.
Time frame: SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy
Change in Time to Diagnosis of SND Before and After Intervention
Time to diagnosis days (date of diagnosis - date of enrollment)
Time frame: From date of enrollment until date of SND diagnosis, assessed up to 60 months
Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
Time to implant in days (date of implant - date of diagnosis)
Time frame: From date of SND diagnosis until date of therapy, assessed up to 6 months
Difference in QoL Between Implant Visit and 6 Months Post-implant
The difference in quality of life was assessed using the SF-12 survey, with higher numbers indicating a better quality of life for the patient. The possible physical score ranges are between 24.0 and 56.6. The possible mental score ranges are between 19.1 and 60.8. Only the difference over time was reported.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dhaka, Bangladesh
United Hospital Limited
Dhaka, Bangladesh
CARE Hospitals
Hyderabad, Andhra Pradesh, India
Care Insitute of Medical Sciences
Ahmedabad, Gujarat, India
RajaRajeswari Medical College & Hospital
Bangalore, Karnataka, India
Max Balaji Hospital
New Delhi, National Capital Territory of Delhi, India
Madras Medical Mission Institute of Cardiovascular Diseases
Chennai, Tamil Nadu, India
King George's Medical University
Lucknow, Uttar Pradesh, India
The Mission Hospital
Durgapur, West Bengal, India
...and 11 more locations
Time frame: between implant visit and 6 months post-implant
Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant
The difference in caregiver burden was assessed using a Zarit survey, with lower numbers indicating a decreased burden or a better outcome for the caregiver. The possible range of scores was between 0 and 88. Only the difference in scores over time were reported.
Time frame: between implant visit and 6 months post-implant