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
- 1
- 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.
研究组 & 干预措施
SystemCHANGE (TM)
SystemCHANGE™ focuses on using patients' already established and reliable systems to support medication-taking, rather than focusing on personal effort and "remembering."When applied to medication adherence, the goal is to reduce medication-taking variability and move towards consistently taking medication with a 6-hour window of time (for daily medications like RAAS) and avoid missing medications. SystemCHANGE™ improvement cycles rely on efficient use of performance feedback in order to make decisions about whether system solutions work or if there is a need to select other solutions.
干预措施: SystemCHANGE (TM) (Behavioral)
Attention Control
Participants in the attention control will receive educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and living with CKD.
干预措施: Attention Control (Other)
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.
Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)
时间窗: 8 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)
- Outcome Expectancy Questionnaire(8 Weeks)
- Credibility Questionnaire(8 weeks)
- Personal Systems Thinking(8 Weeks)
研究者
Rebecca Jane Ellis
Associate Professor
Indiana University