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临床试验/NCT04956406
NCT04956406Unknown不适用

The Effect of Motivational Interviewing on Self-Management in Adult Kidney Transplant Recipients Versus Routine Care

Akdeniz University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Self-management scale

研究概览

简要总结

Purpose: This study aimed to determine the effect of motivational interviewing on self-management of treatment regimen, medication adherence, and patient outcomes in adult kidney transplant recipients between 3 months and 6 months after kidney transplant in the transplant outpatient clinic.

Design: The research is a single-centered, single-blind, parallel and 1:1 randomized active comparative experimental study.

Method: A total of 80 individuals, of the 40 in the control group and 40 in the intervention group, will be included in the study. Motivational interview sessions for the intervention group will be held 3 times between 15-30 minutes with an interval of 10 days. The control group will be given routine care (approximately 1 hour of face-to-face standard training) by the nurse educator. Within the research pattern, intervention and control groups will be applied pre-test at the first interview and post test after one month. In addition, follow-up test will be performed 3th month. The data will be obtained using the Self-Management Scale in Kidney Transplant Recipients, Visual Analog Scale (VAS) for self-care and VAS for medication adherence. In the study, Standard Protocol Items: Recommendations for Interventional Trials- SPIRIT(2013) and CONSORT 2010 (Consolidated Standards of Reporting Trials) were used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

The statistician will be blinded to avoid evaluator bias.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the study,
  • aged ≥18 years old
  • 3-6 months after kidney transplant
  • Speaking, reading and writing in Turkish
  • Having a mobile phone

排除标准

  • Request to leave work
  • Removing Criteria:
  • Development of rejection

结局指标

主要结局

Self-management scale

时间窗: Change from Baseline Self Management at 3 months

The scale Turkish version includes 13 items, and it is likert type with 4 steps. Scale items are scored as 1 "never applied", 2 "applied slightly", 3 "applied very often" and 4 "fully applied". It is recommended to perform calculation based on the item mean scores instead of an overall mean. The lowest possible score obtained from each item and sub-scale is 1 and the highest possible score is 4. The scale has no cutoff points and reversed items.

VAS for medication adherence

时间窗: Change from Baseline VAS for Medication Adherence at 3 months

Medication adherence will be evaluated with self reported scale the visual analog scale ranges from 0 to 100. Rating will be of 0 "taken no medications" to 100 "taken medications perfectly". A score different from 100 will be considered a non adherence

VAS for self care

时间窗: Change from Baseline VAS for self care at 3 months

The rating will be done as 0-100. 0: "I cannot provide my own care".100:"I am able to provide my own care".

次要结局

  • Serum Creatinine(Change from Baseline Serum Creatinine at 3 months)
  • Glomerular Filtration Rate (GFR)(Change from Baseline GFR at 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cigdem Erdem

Research Asistant

Akdeniz University

研究点 (1)

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