Supporting the Medication Adherence of Older Mexican Adults Through External Cues Provided With Ambient Displays: Protocol of a Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change from Baseline Dosage_pill
研究概览
简要总结
Background: Problems with prospective memory, which refer to the ability to remember future intentions, cause deficits in basic and instrumental activities of daily living, such as taking medications. Older adults show minimal deficits when they rely on mostly preserved and relatively automatic associative retrieval processes. On the basis of this, the investigators of this study propose to provide external cues to support the automatic retrieval of an intended action, that is, to take medicines. To reach this end, the Medication Ambient Display (MAD) was developed. It is a system that unobtrusively presents relevant information unless it requires the users' attention, It uses different abstract modalities to provide external cues that enable older adults to easily take their medications on time and be aware of their medication adherence.
Objective: This study aimed to assess the adoption and effect of external cues provided through MAD on medication adherence in older adults. The study aimed to address the following research questions:
- What is the effect of the external cues provided by the MAD on older adults' medication adherence?
- How do the MAD design features promote its adoption?
Methods: A total of 16 older adults, who took at least three medications and had mild cognitive impairment, participated in the study. It was a 17-week feasibility study in which we used a mixed-methods approach to collect qualitative and quantitative evidence. The study included participants' recruitment, baseline, intervention, and postintervention phases. Half of the participants were randomly allocated to the treatment group (n=8), and the other half was assigned to the control group (n=8). Research assistants measured medication adherence weekly through the pill counting technique. Qualitative evidence about the system's adoption was collected through semi-structured interviews. Participants of the treatment group were interviewed regarding the system's functionalities that they perceived as most useful, less useful, and the difficulties faced while using it.
详细描述
- Introduction
One of the most common reasons for medication nonadherence among older adults is forgetfulness. Medication management technologies can help them not only with forgetfulness or cognitive impairment but also with other reasons that contribute to the lack of adherence to medications, such as polypharmacy (ie, the self-administration of multiple drugs). Research has also shown that the use of external cues supports the automatic recovery of a planned action. Therefore, this study proposes to support external cues through a tablet-based ambient display designed to increase the retrieval process of the planned action (ie, taking medications) and to provide awareness of adherence behavior. To reach this end, the Medication Ambient Display (MAD) was developed.
An ambient display unobtrusively presents relevant information unless it requires the users' attention. In addition, users can easily monitor the display to obtain the desired information because it uses abstract modalities to represent information, such as pictures, sounds, and movement. Thus, different abstract modalities to provide external cues that enable older adults to easily obtain relevant information to take their medications on time and be aware of their medication adherence.
MAD was implemented for Android tablets to be placed as portrait frames in the older adults' homes and to provide the following external cues:
- Abstract and stylized representations of their medication adherence
- Auditory and visual reminders to call older adults' attention
- Events that may enhance older adults' awareness about whether the medication was taken.
In this study, the effect of the use of the above-mentioned approach was assessed by using objective medication adherence measures. Moreover, qualitative findings were obtained about the adoption of the MAD. 2. Study flow
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be older than 60 years
- •take at least three medications prescribed by a physician (ie, polypharmacy),
- •have mild cognitive impairment
- •report medication-forgetting events,
- •live with a relative who could report the assistance required by the study participants to take their medications.
排除标准
- •being unable to self-administer medications due to a functionality problem or severe cognitive impairment,
- •not taking pill-based medications (it may be difficult to assess adherence otherwise).
- •To participate in the study, it was not a requirement that older adults have experience in the use of the internet or mobile devices.
结局指标
主要结局
Change from Baseline Dosage_pill
时间窗: 5-week period for baseline
It measures whether the medication is not being taken as prescribed before using MAD. It is the result of dividing the number of pills taken by participants in a period by the number of pills expected to be taken for that period. To assess the dosage_pill, research assistants collected data weekly from each participant through the pill counting technique. It was estimated for each group (TG and CG).
Change from Intervention Dosage_pill
时间窗: 5-week period for intervention
It measures whether the medication is not being taken as prescribed during the use of MAD. It is the result of dividing the number of pills taken by participants in a period by the number of pills expected to be taken for that period. To assess the dosage_pill, research assistants collected data weekly from each participant through the pill counting technique. It was estimated for each group (TG and CG).
Change from Post-Intervention Dosage_pill
时间窗: 2-week period after withdrawal of MAD
It measures whether the medication is not being taken as prescribed after the withdrawal of MAD. It is the result of dividing the number of pills taken by participants in a period by the number of pills expected to be taken for that period. To assess the dosage_pill, research assistants collected data weekly from each participant through the pill counting technique. It was estimated for TG.
次要结局
- Dosage_MAD(5-week period for intervention)
- Timely(5-week period for intervention)
- Baseline Self-reported medication adherence(Once, in the last day of baseline period)
- Change from Intervention Self-reported medication adherence(Once, in the last day of the intervention period)
研究者
Marcela D. Rodriguez
Full Time Professor
Universidad Autonoma de Baja California