Revealing Engagement Dynamics Among Diabetic Kidney Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetic Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Studying Patterns in Patient Engagement and Participation in Diabetic Kidney Disease Clinical Trials
Overview
The study intends to investigate the personal experiences of diabetic kidney disease patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal. The data collected from this study will help improve future outcomes for all diabetic kidney disease as well as those in under-represented demographic groups.
Primary outcome measures
- Number of patients who decide to enroll in a diabetic kidney disease clinical research [Time frame: 3 months]
- Rate of patients who remain in a diabetic kidney disease clinical trial to trial completion [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with diabetic kidney disease
- Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.
Exclusion criteria
- Refusal of consent
- Women of childbearing potential without a negative pregnancy test; or women who are lactating.
- Any serious and/or unstable pre-existing medical disorders
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
United States · 1 center
- Power Life Sciences — San Francisco
Publications
- Schrauben SJ, Shou H, Zhang X, Anderson AH, Bonventre JV, Chen J, Coca S, Furth SL, Greenberg JH, Gutierrez OM, Ix JH, Lash JP, Parikh CR, Rebholz CM, Sabbisetti V, Sarnak MJ, Shlipak MG, Waikar SS, Kimmel PL, Vasan RS, Feldman HI, Schelling JR; CKD Biomarkers Consortium and the Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. Association of Multiple Plasma Biomarker Concentrations w PMID 33122288
- Tofte N, Lindhardt M, Adamova K, Bakker SJL, Beige J, Beulens JWJ, Birkenfeld AL, Currie G, Delles C, Dimos I, Francova L, Frimodt-Moller M, Girman P, Goke R, Havrdova T, Heerspink HJL, Kooy A, Laverman GD, Mischak H, Navis G, Nijpels G, Noutsou M, Ortiz A, Parvanova A, Persson F, Petrie JR, Ruggenenti PL, Rutters F, Rychlik I, Siwy J, Spasovski G, Speeckaert M, Trillini M, Zurbig P, von der Leyen PMID 32135136
- Chan L, Nadkarni GN, Fleming F, McCullough JR, Connolly P, Mosoyan G, El Salem F, Kattan MW, Vassalotti JA, Murphy B, Donovan MJ, Coca SG, Damrauer SM. Derivation and validation of a machine learning risk score using biomarker and electronic patient data to predict progression of diabetic kidney disease. Diabetologia. 2021 Jul;64(7):1504-1515. doi: 10.1007/s00125-021-05444-0. Epub 2021 Apr 2. PMID 33797560
Identifiers
NCT: NCT06101901 · 63894857