Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Oct;102(1):25-34.
doi: 10.1016/j.diabres.2013.06.004. Epub 2013 Sep 17.

Adherence and renal biopsy feasibility in the Renin Angiotensin-System Study (RASS) primary prevention diabetes trial

William N Robiner  1 , Trudy D Strand, Michael Mauer; Renin Angiotensin System Study (RASS) Group
Affiliations
Randomized Controlled Trial

Adherence and renal biopsy feasibility in the Renin Angiotensin-System Study (RASS) primary prevention diabetes trial

William N Robiner et al. Diabetes Res Clin Pract. 2013 Oct.

Abstract

Aims: Enhancing adherence in research trials is fundamental to the proper testing of treatment hypotheses.

Methods: Regimen and follow-up adherence as well as factors associated with adherence in the Renin Angiotensin-System Study (RASS) diabetic nephropathy primary prevention trial were evaluated. Adherence to medication (i.e., pill count), follow-up visits, and follow-up renal biopsies was evaluated.

Results: 89.8% of subjects completed the second renal biopsy. 96% of follow-up visits were attended within prescribed time windows. Mean medication adherence was 85.6%. Subgroup analyses revealed greater declines in the least adherent participants over time. Factors associated with greater adherence levels included older age, type 1 diabetes (TIDM) duration, lower HbA1c and blood pressure, GFR, ethnicity, and participants', principal investigators' (PI), and trial coordinators' (TC) baseline predictions of adherence.

Conclusions: T1DM patients without nephropathy were willing to take experimental medications and undergo repeat renal biopsies. Although overall adherence was excellent, patterns of adherence varied among participants, suggesting the need to better track adherence and to develop customized and targeted approaches for promoting adherence to clinical research regimens. Staff subjective predictions of adherence were imprecise, supporting need for further development of adherence predictors.

Trial registration: ClinicalTrials.gov NCT00143949.

Keywords: Adherence; Clinical trial; Diabetes; Kidney biopsy; Psychology; Research.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest

There are no conflicts of interest.

Figures

Fig. 1
Fig. 1
Mean medication adherence of subjects enrolled through visit 20. Notes. Visit 20 was the final visit in which pill counts were obtained and when the second renal biopsy was obtained. M = Montreal; T = Toronto; U = Minnesota Center. Center refers to all centers. N = 273.
Fig. 2
Fig. 2
Mean medication adherence of subjects who maintained adherence >85%. Notes. Based on subjects enrolled through visit 20 (the final visit in which pill counts were obtained and when the second renal biopsy was obtained). M = Montreal (58); T = Toronto (74); U = Minnesota (69); Center = All centers combined. n = 201.
Fig. 3
Fig. 3
Mean medication adherence of subjects who maintained adherence 70–85%. Notes. Based on subjects enrolled through visit 20. M = Montreal (11); T = Toronto (9); U = Minnesota (13); Center = All centers combined. n = 33.
See this image and copyright information in PMC

References

    1. Mauer M, Zinman B, Gardiner R, Drummond KN, Suissa S, Donnelly SM, et al. ACE-I and ARBs in early diabetic nephropathy. J Renin-Angiotensin-Aldosterone Syst. 2002;3:262–9. - PubMed
    1. Mauer M, Zinman B, Gardiner R, Suissa S, Sinaiko A, Strand T, et al. Renal and retinal effects of Enalapril and Losartan in type 1 diabetes. N Engl J Med. 2009;361:40–51. - PMC - PubMed
    1. Mauer M, Fioretto P, Woredekal Y, Friedman EA. Diabetic nephropathy. In: Schrier, Gottschalk, editors. Diseases of the kidney. Philadelphia, PA: Lippincott, Williams & Wilkins; 2001. pp. 2083–128.
    1. Klein R, Myers CE, Klein BEK, Zinman B, Gardiner R, Suissa S, et al. Relationship of blood pressure to retinal vessel diameter in type 1 diabetes mellitus. Arch Ophthalmol. 2010;128:198–205. - PMC - PubMed
    1. Klein R, Zinman B, Gardiner R, Suissa S, Donnelly SM, Sinaiko AR, et al. The relationship of diabetic retinopathy to preclinical diabetic glomerulopathy lesions in type 1 diabetic patients: the Renin-Angiotensin System Study. Diabetes. 2005;54:527–33. - PubMed

Publication types

Associated data