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临床试验/CTRI/2024/08/072687
CTRI/2024/08/072687已完成不适用

Effect of Nurse-led mHealth and module-based educational intervention on self-care behaviour, clinical outcomes and quality of life among heart failure patients: Three-arm randomized controlled trial

AIIMS1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
AIIMS
入组人数
240
试验地点
1
主要终点
Self-Care behaviour

研究概览

简要总结

Heart failure (HF) is a complex, multifactorial syndrome resulting from impaired heart function. The estimated prevalence of heart failure (HF) in India is approximately 1% of the Population or about 810 million people and the estimated mortality from heart failure is about 0.10 to 0.16 million people per year. A randomised controlled trial is proposed to examine the nurse led mHealth and module-based educational intervention on self-care behaviour, clinical outcomes and quality of life among heart failure patients. The expected results of the nurse led mHealth and module-based educational intervention would help the heart failure patients to be knowledgeable about their disease, acquire skills needed to monitor and recognize their symptoms and perform adequate self-care. All study participants will receive usual care, which includes all medical, nursing, allied health, and follow-up services provided by the study hospital. After obtaining the participants informed consent the researcher will collect the baseline data. It will include the sociodemographic variables, clinical profile, clinical outcomes, Self-Care of heart failure index (SCHFI), Cardiac self-efficacy scale (CSES), Health related quality of life (HRQoL-Minnesota living with heart failure questionnaire), Symptoms status question heart failure (SSQHF), Medication adherence rating scale. The researcher will contact the participants and arrange appointments to collect post intervention data at 3 months from baseline (T1), and 6 months from baseline (T2). The collected data will be analyzed using descriptive and inferential statistics with software like SPSS 20 and Microsoft Excel, and the results will be presented in the form of tables, graphs, and figures. Findings of the study will be disseminated.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient age 18 years or older
  • Patients or family members who uses android smartphone mobile
  • Patient who had been clinically diagnosed with heart failure
  • Patients who can understand Hindi or English language.
  • Patients who can come to the hospital for follow-up visits.

排除标准

  • Critically ill patients and terminal illness (CKD, ESRD, MODS, COPD) that affect self-care ability and completion of the study.
  • Patients with Class IV Killip heart failure.
  • Patients with Hearing impairment or deafness.
  • Patient with dementia or other mental health disorder (impaired cognitive functioning).
  • No internet access at home.

结局指标

主要结局

Self-Care behaviour

时间窗: Baseline, 3 months, 6 months

Clinical outcomes

时间窗: Baseline, 3 months, 6 months

Quality of life

时间窗: Baseline, 3 months, 6 months

次要结局

  • Re-admission rate(Mortality rate)

研究者

发起方
AIIMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nipin Kalal

AIIMS Jodhpur

研究点 (1)

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