Non-adherence and Polypharmacy in Elderly Patients With Chronic Renal Failure: Predictors and an Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Prevalence for medication non-adherence
研究概览
简要总结
The study aims to investigate adherence and polypharmacy in elderly patients with chronic kidney disease (CKD) and End Stage Renal Disease (ESRD). The investigators look into possible factors or predictors that may affect adherence and reduce polypharmacy. Factors could be: quality of life, anxiety and depression, beliefs about medicine and cognitive impairment.
The investigators are planning an intervention with the screening tool Screening Tool of Older Person's potentially inappropriate Prescription/Screening tool to Alert to Right Treatment (STOPP/START ) criteria to evaluate medication lists of the participating patients.
详细描述
The investigators intend to include all patients > 65 years old, in dialysis treatment (hemodialysis and peritoneal dialysis), as well as patients with CKD stage 5.
The recruitment will be done as follows:
The patients will be screened according to inclusion criteria. Afterwards each patient will be invited to a first meeting that explains the aim of the study, giving the opportunity for discussion and consideration, and presenting the consent information. After giving the consent the patient will be invited to a second meeting with blood tests, data registration, medication registration, undergoing MMS and handing over the questionnaires forms.
Randomization:
After the initial assessment and compliance with the eligibility criteria, participants will be randomized into an intervention group (medication list will be evaluated by STOPP/START criteria) and a control group (medication list will not be evaluated by STOPP/START criteria). Randomization numbers will be generated by a random number generator. A series of numbered, sealed, opaque envelopes will be used to ensure confidentiality. Each envelope will contain a card with information about the group allocation. The group allocation is concealed from the researcher and patients at baseline registration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients > 65 years with CKD, stage 5 (eGFR ≤ 12 ml/min), or undergoing treatment with hemodialysis and peritoneal dialysis
排除标准
- •Patients not willing to participate
- •Patients diagnosed with dementia or severe cognitive disorder (MMS < 25),
- •Patients with hearing impairment
- •Patients with language difficulties
研究组 & 干预措施
Intervention group
Medication lists from the patients randomized in the intervention group will be evaluated by the research physician with the help of STOPP/START criteria.
Feedback of this screening will be given to the team responsible for patient treatment.
干预措施: STOPP/START criteria (Other)
Control
Patients in this arm will receive standard pharmacological treatment
结局指标
主要结局
Prevalence for medication non-adherence
时间窗: 6 months - 1 year
Adherence measured by Morisky medication adherence scale and visual adherence scale
次要结局
- Risk factors for medication non-adherence(6 months - 1 year)
- Association between beliefs about medication and anxiety and depression with medication non-adherence and quality of life(1-2 years)
- Improvement of polypharmacy(1-2 year)
- Improvement of adherence(1-2 year)
- Predictors for medication non-adherence(6 months - 1 year)
- Non-adherence and medication - predictors(6 months - 1 year)
- Medication non-adherence risk factors(6 months - 1 year)
研究者
Krystina Parker
MD, pHD-student
University Hospital, Akershus