Effectiveness of using manual pill organizers and pill reminder apps in improving medication adherence and health outcomes in elderly patients receiving multiple medications
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 752
- 试验地点
- 3
- 主要终点
- Assessment of medication adherence using Medication adhrence rating system - 5 (MARS-5), Self reported seven days point prevalence of medication non-adherence and pill count.
研究概览
简要总结
Title: Effectiveness of using manual pill organizers and/or pill reminder apps in improving medication adherence and health outcomes in elderly patients receiving multiple medications
Background: Approximately 40-75% of the elderly individuals suffering from chronic diseases have been found to be nonadherent to treatment. There is no evidence on effectiveness of pill organisers and pill reminder apps in Indian geriatric population.
Study objectives: The primary objective is to assess effectiveness of pill organisers and pill reminder apps singly or in combination for improving medication adherence in elderly patients receiving multiple medications. Additionally, we will evaluate the feasibility of use and impact on health utilization, adverse clinical outcomes and cost-utility.
Methods: Study population will include medically stable elderly participants aged 60-80 years diagnosed with one or more noncommunicable diseases, receiving 3 or more medications for the past 6 months and willing to participate in the study. The phase 1 study will pilot test feasibility and acceptability of the interventions in 60 participants using mixed methods and will be conducted at VRHP, KEMHRC, Pune. Based on the results of this study the pill box and pill reminder app will be optimized for the next phase. Phase 2 will be a randomised open-labelled study to evaluate the impact of manual pill organisers and/or pill reminder app in 752 elderly population on medication adherence, health, and quality of life. The participants will be followed up at 3, 6 and 12 months for medication adherence outcomes, health outcome, quality of life and cost-utility outcomes.
Endpoints:
· Change in medication adherence [measured using medication adherence rating scale (MARS-5)], Seven days point prevalence and pill count at baseline, 3, 6 and 12 months
· Assessment of acceptability and barriers in the use of manual pill organisers and pill reminder apps alone or in combination amongst elderly population
· Health care utilization (hospitalization, emergency department visits, outpatient visits and general practitioner visits) at 3,6 and 12 months
· Adverse clinical outcomes at 3, 6 and 12 months
· Quality of life (using EQ5D5L) at baseline and 12 months.
· Incremental cost effectivenss and cost utility ratio at baseline and 12 months.
Expected outcome and impact:
The study will provide definitive evidence on the use of pill organisers and pill reminder apps in Indian geriatric population in terms of improvement in medication adherence as well as health and economic outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Medically stable elderly individuals aged 60-80 years diagnosed with one or more noncommunicable diseases (E.g. hypertension, diabetes, hypercholesteremia, bronchial asthma, chronic obstructive lung disease) -Prescribed with three or more oral medications for at least past 6 months and are able to self-administer the medications.
- •Planning to stay in the study area for next one year.
- •Access to a smartphone within the family throughout the day and knowledge to use it.
- •Willing to participate in the study.
排除标准
- •History of hospitalisation during last one month -Individuals diagnosed with any mental or cognitive dysfunction (e.g. Schizophrenia, Alzheimer’s disease) -Individuals with expected life expectancy of less than one year (e.g. severe debility due to advanced age, advanced stage malignant cancers) -Used pill organiser or pill reminder app for improving medication adherence in the past.
- •Any other condition that in the opinion of the investigator jeopardises the health and wellbeing of the participant in case of participation.
结局指标
主要结局
Assessment of medication adherence using Medication adhrence rating system - 5 (MARS-5), Self reported seven days point prevalence of medication non-adherence and pill count.
时间窗: MARS-5 and seven days point prevelence of medication non-adhrence will be assessed at 3, 6 and 12 months. Pill counts will be assessed at the end of each quarter during 12 months follow up.
次要结局
- Assessment of acceptability and barriers for the use of manual pill organisers and pill reminder apps(The acceptability and barriers will be evaluated through the qualitative study in phase 1.)
- Health care utilisation(Number of hospitalisation or emergency department visits or outpatient visits or general practitioner visits will be measured at 3,6 and 12 months)
- Adverse clinical outcomes(Any clinically significant events that may impact on healthcare utilisation and mortality (at 3, 6 and 12 months))
- Quality of Life, cost effectiveness & cost-utility ratio(Quality of life will be assessed at baseline & 12 months using EQ5D5L. Cost for development of each study intervention will be calculated. Cost-effectiveness will be calculated against the primary outcome of medication adherence. The incremental cost-utility ratio will be calculated as additional cost required to have unit change in the quality of life.)
研究者
Aditi Apte
Vadu Rural Health Program, KEM Hospital Research centre