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
. 2012 Apr 25:12:16.
doi: 10.1186/1471-2318-12-16.

Proactive and integrated primary care for frail older people: design and methodological challenges of the Utrecht primary care PROactive frailty intervention trial (U-PROFIT)

Nienke Bleijenberg  1 , Irene Drubbel, Valerie H Ten Dam, Mattijs E Numans, Marieke J Schuurmans, Niek J de Wit
Affiliations
Randomized Controlled Trial

Proactive and integrated primary care for frail older people: design and methodological challenges of the Utrecht primary care PROactive frailty intervention trial (U-PROFIT)

Nienke Bleijenberg et al. BMC Geriatr. .

Abstract

Background: Currently, primary care for frail older people is reactive, time consuming and does not meet patients' needs. A transition is needed towards proactive and integrated care, so that daily functioning and a good quality of life can be preserved. To work towards these goals, two interventions were developed to enhance the care of frail older patients in general practice: a screening and monitoring intervention using routine healthcare data (U-PRIM) and a nurse-led multidisciplinary intervention program (U-CARE). The U-PROFIT trial was designed to evaluate the effectiveness of these interventions. The aim of this paper is to describe the U-PROFIT trial design and to discuss methodological issues and challenges.

Methods/design: The effectiveness of U-PRIM and U-CARE is being tested in a three-armed, cluster randomized trial in 58 general practices in the Netherlands, with approximately 5000 elderly individuals expected to participate. The primary outcome is the effect on activities of daily living as measured with the Katz ADL index. Secondary outcomes are quality of life, mortality, nursing home admission, emergency department and out-of-hours General Practice (GP), surgery visits, and caregiver burden.

Discussion: In a large, pragmatic trial conducted in daily clinical practice with frail older patients, several challenges and methodological issues will occur. Recruitment and retention of patients and feasibility of the interventions are important issues. To enable broad generalizability of results, careful choices of the design and outcome measures are required. Taking this into account, the U-PROFIT trial aims to provide robust evidence for a structured and integrated approach to provide care for frail older people in primary care.

Trial registration: NTR2288.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flowchart.
See this image and copyright information in PMC

References

    1. United Nations, Department of Economic and Social Affairs, Population Division. World Population Ageing: 1950-2050. 2002.
    1. Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J. et al.Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56(3):M146–M156. doi: 10.1093/gerona/56.3.M146. - DOI - PubMed
    1. Ferrucci L, Guralnik JM, Studenski S, Fried LP, Cutler GB Jr, Walston JD. Designing randomized, controlled trials aimed at preventing or delaying functional decline and disability in frail, older persons: a consensus report. J Am Geriatr Soc. 2004;52(4):625–634. doi: 10.1111/j.1532-5415.2004.52174.x. - DOI - PubMed
    1. Pel-Littel R, Schuurmans M, Emmelot-Vonk M, Verhaar HJJ. Frailty: defining and measuring of a concept. J Nut Health Aging. 2009;13(4):390–394. doi: 10.1007/s12603-009-0051-8. - DOI - PubMed
    1. Schuurmans H, Steverink N, Lindenberg S, Frieswijk N, Slaets JPJ. Old or frail: what tells us more? J Gerontol Series A: Biol Sci Med Sci. 2004;59(9):M962.. - PubMed

Publication types

LinkOut - more resources