NCT04633993

Effectiveness of Implementation of a Patient-centered Self-management Program in Patients With Hypertensive Nephropathy

Completed NA Last updated 7 April 2022

What this trial tests

NA trial testing PCSMP in Hypertensive Nephropathy in 70 participants. Completed in 30 November 2021.

Timeline

2 December 2019

Primary endpoint
30 November 2020

30 November 2021

Quick facts

Lead sponsor	National Taipei University of Nursing and Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	70
Start date	2 December 2019
Primary completion	30 November 2020
Estimated completion	30 November 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• PCSMP

Conditions studied

• Hypertensive Nephropathy — all drugs for Hypertensive Nephropathy →
• Self-management — all drugs for Self-management →
• Self-efficacy — all drugs for Self-efficacy →
• Mental Health Wellness 1 — all drugs for Mental Health Wellness 1 →

Sponsor

National Taipei University of Nursing and Health Sciences

Who can join

20 and older, any sex, with Hypertensive Nephropathy or Self-management. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a 2-years project. The year 1 project: to assess the effectiveness of implementation of the program in patients with HN. The experimental research design of 2×2 randomized controlled trial with pre and post-testing will be adopted. A total of 70 subjects will be enrolled, and 35 subjects will be randomized into the control group (conventional program) and experimental group (patient-centered self-management program), respectively, using the single-blind design. Firstly, this study will collect the pretest data of the control group and experimental group. The data to be collected include physiological indicators, physical and psychological health, self-efficacy, self-management, and satisfaction, etc. The experimental group will receive the 4-week intervention of program after the pre-test. This study will assess the effectiveness of intervention 1 month later. This study will use generalized estimating equation (GEE) to collect the longitudinal data and test the effectiveness of implementation of program in patients with HN at different time points (after 1, 3, and 6 months). It is expected that the completion of this research project may help improve the effective disease control in the care for patients with HN in Taiwan and improve self-management of disease. Hopefully, the incidence of patients with dialysis can be significantly reduced and the progression into ESRD in patients can be effectively delayed. Moreover, this study also intends propose specific suggestions about the care of patients with HN for industry, government, and academia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of patient-centred self-management programme on mental health, self-efficacy and self-management of patients with hypertensive nephropathy: A randomised controlled trial.
   Lee MC, Wu SV, Lu KC, Wang WH, et al · · 2021 · cited 1× · PMID 33942419 · DOI 10.1111/jocn.15825