Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)
研究概览
简要总结
The purpose of this 2-group, randomized, controlled trial is to evaluate the refined SystemCHANGE™ against attention control patient education in CKD patients taking RAAS medications.
详细描述
In this study, the investigators will test a refined SystemCHANGE™ in patients taking RAAS inhibiting medications. Participants will be recruited from two sources: 1) the largest and most comprehensive health care system in the state and 2) one of the largest essential health care systems in the country. Data are collected at baseline, 8 weeks (immediately post-intervention), and 12 weeks.
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 (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •prescribed at least 1 daily RAAS inhibiting medication
- •CKD diagnosis estimated glomerular filtration rate (eGFR) category G1 to G4
- •RAAS inhibiting medication adherence of <.85 documented during the screening phase
- •proteinuria defined as a urine Protein-to-Creatinine ratio > 150 mg/g or urine Albumin-to-Creatinine ratio >30mg/g
- •able to speak, hear, and understand English determined by the ability to participate and comprehend conversation about potential inclusion in the study
- •self-reported ability to open a pill cap
- •able to self-administer RAAS inhibiting medications
- •willing to use a study phone
- •has no cognitive impairment as determined by a score of 4 or greater on the 6-item Telephone Mental Status Screen Derived from the Mini-Mental Status Exam (cognitive screener)
- •has no other diagnoses that may shorten life span, such as metastatic cancer
- •is not currently hospitalized
- •receives care through two approved health care systems
排除标准
- •Participants with kidney failure defined by GFR <15 mL/min/1.73
- •Participants will be excluded if they are receiving dialysis or have dialysis access placed (e.g. graft or arteriovenous fistula) in anticipation of starting dialysis.
- •Kidney and kidney-pancreas transplant recipients will be excluded.
结局指标
主要结局
Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)
时间窗: 12 Weeks
Monitored by electronic MEMS caps (AARDEX Group, Belgium) which record the date and time the cap is removed as a proxy for medication being taken.
次要结局
- Number of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability.(12 weeks)
- Outcome Expectancy Questionnaire(12 Weeks)
- Credibility Questionnaire(12 Weeks)
- Personal Systems Thinking(12 weeks)
研究者
Rebecca Jane Ellis
Associate Professor
Indiana University