Nurse Led Intervention on Self Care Adherence and Quality of Life
报名条件（概要）
- 年龄：18 Years – 69 Years
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
Nepal
药品与企业信息
其他名称：Laptop based education and counselling sessions、Telephopne reminder、Distribution of booklet
1\. Education and counselling session by nurses (laptop-based): 4 session each with 20-30 minutes * 1st session (1 to 2 weeks):The nurse makes patients aware of existing interdialytic weight gain status, blood pressures, body mass index, and physical activity. Covers a brief introduction of kidney, its functions, chronic kidney disease, treatment options, dry weight, and its importance, motivational examples and the need for behavior change. * 2nd session (3 to 4th weeks): Increase awareness about healthy behavior, introduction to diet, salt, and fluid, and dietary recommendation session for sodium, show foods high and low in potassium, phosphorus, and protein, monitoring serum values, and strategies to reduce salt and fluid intake * 3rd Session (5- 6th week): Increase awareness and importance of physical activity and recommended physical activity for participants * 4th session (7- 8th week): Introduction to mental health and strategies to improve mental health
Participants will be called 4-6 times , once a week on non dialysis day for 3-5 minutes after 2nd session up to 4 months from baseline .
Self care booklet for hemodialysis patients. Books conatins introduction to kidney, chronic kidney disease , its function . This book covers almost all the contents covered in discussion session. It contains the picture of locally avialable spoon with 5 gm salt , locally avilable glass having 100 ml line, list of tables on vegetables and fruits with the potassium and phosphorus in milligrams .
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
Background: Hemodialysis is the most common treatment modality in patients with chronic kidney disease. The majority of people with dialysis have a below-average quality of life. Adherence to diet and fluid intake, engagement in physical activity, and feeling blue and anxious will all affect quality of life. Nurses play a key role in patient education and behavioral support. Nurse-led interventions, especially educational programs (laptop-based), combined with reminders and educational materials, may improve patients' knowledge, adherence to treatment, and improvement in quality of life. Methodology The study will adopt the quantitative research design .The study will be conducted in a single private tertiary care center. First, the day and shift were randomized, and participants belonging to the particular day and shift will be considered as Group A and Group B. After this, the eligibility criteria will be assessed, and the baseline assessment will be done. A convenient sampling technique will be used to select the study sample. The sample will be a minimum of 56 in each arm. Therefore, altogether there will be at least 112 participants. One group will receive nurse-led interventions (Group A), and the control group (Group B) will receive usual routine care. Nurse-led intervention comprises 4 laptop-based educational and counseling sessions, 4-6 telephone reminders, and the distribution of the booklet on self-care. All four sessions will be conducted by the specialist nurse or nurse with at least one year of working experience in a dialysis unit. Each session will be conducted once every one to two weeks. The primary outcome will be self-care adherence. The self-care adherence will be measured by direct assessment of clinical parameters (interdialytic weight gain) of adherence and subjectively through face-to-face interviews. Patients' medical records will be reviewed. The secondary outcome will be the quality of life score. An independent assessor (enumerator) will measure the outcome at T1 and T2, which will be done at 4 months (T1) and 6 months (T2) from the baseline. Analysis will be done through the Stata software version 14. Descriptive statistics like frequency, percentage, mean±sd, median, inter quartile range are based on the nature of the data. Similarly, inferential statistics such t t-test and linear regression analysis will be used to find out the difference in mean score between two groups. The findings will be considered statistically significant at level p\<0.05 at 95% CI. The strength of this study will be the inclusion of both clinical and subjective parameters of adherence and assessment of quality of life. Use of a qualitative approach in explaining the factors, like appropriateness of the education and counselling session, along with the facilitators and barriers to adherence, will further help to modify the interventions. If the method is found to be effective, this will be an effective measure to improve quality of life cost-effectively. This can be continued on a regular basis in the same center and can be utilized in others, too.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Abja Sapkota, Masters in Nursingabjasapkota@nmcth.edu(+977)9841370401
研究中心联系方式
- Nepal Medical College Teaching HospitalGokarna，Bagmati，Nepal
- Nepal Medical College and Teaching HospitalKathmandu，Bagmati，Nepal
问自己是否符合条件、如何预筛
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Nurse Led Intervention on Self Care Adherence and Quality of Life ClinicalTrials.gov Identifier: NCT07506980 Sponsor: Kathmandu University School of Medical Sciences Investigational product: laptop based education and counselling, Reminder call, distribution of self care booklet having all the content covered in discussion About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Nurse Led Intervention on Self Care Adherence and Quality of Life 试验编号：NCT07506980 申办方：Kathmandu University School of Medical Sciences 研究药物：laptop based education and counselling、Reminder call、distribution of self care booklet having all the content covered in discussion 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。