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

Summary

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.

Conditions

• Hypertensive Nephropathy
• Self-management
• Self-efficacy
• Mental Health Wellness 1

Interventions

BEHAVIORAL

PCSMP

This study divided the patient-centered self-management manual for patients with hypertensive nephropathy into 4 units, including: Unit 1: hypertensive nephropathy brief introduction and complications. Unit 2: dietary precautions for patients with hypertensive nephropathy. Unit 3: medication treatments for patients with hypertensive nephropathy. Unit 4: the content included stress management (emotional control, spiritual support). This program was implemented in small groups with 5-10 patients. This study used patient-centered self-management group activity manual as the tool. The group activities with 4 units lasting for 400 minutes were expected to be designed. The group activities were expected to last for 4 weeks and be implemented once per week and 100 minutes per time (including: 90 minutes of group discussion and 5-10 minutes of video-waring).

Sponsors & Collaborators

• Cardinal Tien Hospital

  collaborator OTHER

• National Taipei University of Nursing and Health Sciences

  lead OTHER

Principal Investigators

• Mei-Chen Lee, PhD · National Taipei University of Nursing and Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-02

Primary Completion

2020-11-30

Completion

2021-11-30

Countries

• Taiwan

Study Locations