Clinical trial NCT04633993: Effectiveness of Implementation of a Patient-centered Self-management Program in Patients With Hypertensive Nephropathy
Official title: Effectiveness of Implementation of a Patient-centered Self-management Program in Patients With Hypertensive Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertensive Nephropathy
Self-management
Self-efficacy
Mental Health Wellness 1
Keywords: hypertension
hypertensive nephropathy
chronic kidney disease
end-stage kidney disease,
patient-centered,
self-management program
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Cardinal Tien Hospital
First posted: 2020-11-18
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Since population aging is accompanied by chronic diseases. Hypertension is a type of chronic disease, and poor to control the symptoms of hypertension may accelerate the progression of renal function into hypertensive nephropathy (HN) and ultimately lead to dialysis. 2017 annual report on kidney disease in Taiwan published by The Taiwan Society of Nephrology showed that among the comorbidities experienced by new patients before the 1year dialysis, hypertension ranked the first (89.5%). In Taiwan, the prevalence and incidence of end-stage renal disease (ESRD) both are ranked high in the world, which has an impact on the aspects of individual, family, society, etc. and jeopardizes the financial situation of the government's national health insurance. Therefore, in order to effectively reduce the incidence of ESRD and delay the progression of HN, the implementation of a patient-centered self-management program may effectively reduce medical costs and improve patients' quality of life. 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 G power statistical analysis to calculate the sample size and use SPSS/Windows 20.0 for recording and statistical analysis. For the statistical analysis methods, this study will use repeated measure ANOVA to analyze the effectiveness of intervention. The year 2 project is to extend the year 1 research project. 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypertensive nephropathy and chronic kidney disease stage 3b to 5.
* Clear consciousness and could communicate in Chinese and Taiwanese
* Age 20 years old the above.

Exclusion Criteria:

* End-stage kidney disease who have undergone dialysis treatment (hemodialysis, peritoneal dialysis)
* Clinical diagnosis of diabetic nephropathy
* Diagnosed as mental illness (severe depression, schizophrenia) and cognitive dysfunction

Primary outcomes:
measure: Hypertensive nephropathy self-management instrument (HN-SM)
timeFrame: 1st month, 3th month, and 6th month after recruited.
Secondary outcomes:
measure: World Health Organization-5 Well Being Index (WHO-5)
timeFrame: 1st month, 3th month, and 6th month after recruited.
measure: The hypertensive nephropathy self-efficacy instrument (HN-SE)
timeFrame: 1st month, 3th month, and 6th month after recruited.
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Cardinal Tien Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Mei-Chen Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varleta P, Tagle R. A feared combination: Hypertension and chronic kidney disease. J Clin Hypertens (Greenwich). 2019 Jan;21(1):102-104. doi: 10.1111/jch.13432. Epub 2018 Nov 14. No abstract available.
citation: Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.
citation: Aryee C, Owiredu WK, Osei-Yeboah J, Owusu-Dabo E, Laing EF, Owusu IK. An Analysis of Anthropometric Indicators and Modifiable Lifestyle Parameters Associated with Hypertensive Nephropathy. Int J Hypertens. 2016;2016:6598921. doi: 10.1155/2016/6598921. Epub 2016 Sep 27.
citation: Lin CC, Wu CC, Wu LM, Chen HM, Chang SC. Psychometric evaluation of a new instrument to measure disease self-management of the early stage chronic kidney disease patients. J Clin Nurs. 2013 Apr;22(7-8):1073-9. doi: 10.1111/j.1365-2702.2011.04048.x. Epub 2012 May 30.
citation: Chow CK, Teo KK, Rangarajan S, Islam S, Gupta R, Avezum A, Bahonar A, Chifamba J, Dagenais G, Diaz R, Kazmi K, Lanas F, Wei L, Lopez-Jaramillo P, Fanghong L, Ismail NH, Puoane T, Rosengren A, Szuba A, Temizhan A, Wielgosz A, Yusuf R, Yusufali A, McKee M, Liu L, Mony P, Yusuf S; PURE (Prospective Urban Rural Epidemiology) Study investigators. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA. 2013 Sep 4;310(9):959-68. doi: 10.1001/jama.2013.184182.
citation: Nguyen NT, Douglas C, Bonner A. Effectiveness of self-management programme in people with chronic kidney disease: A pragmatic randomized controlled trial. J Adv Nurs. 2019 Mar;75(3):652-664. doi: 10.1111/jan.13924. Epub 2019 Feb 14.
citation: Wu SFV, Lee MC, Hsieh NC, Lu KC, Tseng HL, Lin LJ. Effectiveness of an innovative self-management intervention on the physiology, psychology, and management of patients with pre-end-stage renal disease in Taiwan: A randomized, controlled trial. Jpn J Nurs Sci. 2018 Oct;15(4):272-284. doi: 10.1111/jjns.12198. Epub 2017 Dec 20.
citation: Lee MC, Wu SV, Lu KC, Wang WH, Chen YY, Tai CY. Effect of Patient-Centered Self-Management Program on Blood Pressure, Renal Function Control, and the Quality of Life of Patients With Hypertensive Nephropathy: A Longitudinal Randomized Controlled Trial. Biol Res Nurs. 2022 Apr;24(2):216-225. doi: 10.1177/10998004211061877. Epub 2021 Dec 29.
citation: Lee MC, Wu SV, Lu KC, Wang WH, Chen YY, Chen HM. Effect of patient-centred self-management programme on mental health, self-efficacy and self-management of patients with hypertensive nephropathy: A randomised controlled trial. J Clin Nurs. 2021 Nov;30(21-22):3205-3217. doi: 10.1111/jocn.15825. Epub 2021 May 3.