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临床试验/NCT04413500
NCT04413500Unknown不适用

iMedA: Improving MEDication Adherence Through Person Centered Care and Adaptive Interventions

Halmstad University0 个研究点目标入组 32 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
32
主要终点
change from baseline medication adherence score at 6 months

研究概览

简要总结

The aim of this study is to design, implement, and evaluate an adaptive personalized digital intervention, to be delivered through a mobile application, to increase medication adherence and self-care management for persons with hypertension. This is a collaborative project between Halmstad University and Region Halland in Halland county, Sweden.

The project is divided into three steps: 1)Focus groups 2)pilot study 3)Longitudinal study. The design of the study is influenced by the Intervention Mapping technique, which is used for the design and development of health promotion programs. The investigators first conducted a systematic review in order to detect the determinants, behaviors to change, and implemented digital strategies in the previous studies. The result was drawn in the Matrix of Change Objectives to facilitate the mapping. Then through focus groups, the investigators are going to ascertain the needs of the Swedish context. Through what has been learned with these findings, digital interventions will be designed and developed to be delivered via mobile application. A pilot study is considered then to evaluate the feasibility and usability testing of digital intervention. Finally, a longitudinal study is designed to evaluate the effectiveness of the digital intervention in the longer term. The design is proposed to be an interrupted time series (ITS) approach which is considered to be the strongest quasi-experimental design that can be used to evaluate the effectiveness of an intervention.

详细描述

The design of the digital intervention module is considered to follow the just-in-time adaptive intervention framework (JITAI). JITAI is an intervention design aiming to provide the right type/amount of support, at the right time, by adapting to an individual's circumstances. It has enormous potential for promoting health behavior change, which in this study is supposed to be medication compliance. Based on the JITAI's conceptual model, there are the following components:

  1. Decision points (DP) DP is a time when an intervention decision is made. Considering the nature of JITAIs which are delivered through mobiles, DPs are much more rapidly than is standard interventions. In iMedA, DP is considered to be daily and accompanied by the time of medication intake question, i.e. "Did the participant take the anti-hypertensive medication today?".
  2. Intervention options (IO) IOs are a set of possible interventions that are going to be delivered at DPs. In JITAI, IOs can be various types of support (information, advice, feedback, etc), source of support (mobile, nurse, physician, etc), amounts of support (intensity, dose, etc), type of media/channel (phone call, SMS, etc).

From the conducted literature review, the investigators summarised all types of digital interventions to hypertensive patients as:

  • Reminders for medication intake (daily), BP measurement (monthly), PA (biweekly)
  • Informational contents regarding hypertension and all its facts, consequences, treatments, risks, medications and side-effects, lifestyle, and so on (text, videos, etc)
  • Trends on medication intake/PA/BP/etc
  • Motivational messages
  1. Distal outcomes (DO) DO is the ultimate goal that the intervention is trying to achieve. In iMedA, the investigators considered primary and secondary DOs. Primarily the investigators aim at improving medication adherence. Then in the long term, blood pressure control is considered as secondary DOs besides the increased quality of life, assessment of the lifestyle behavior (smoking, alcohol consumption, physical activity, and food intake), and communicative and critical health literacy.

In order to measure MA, the investigators consider (1) self-reported medication intake through a mobile app; (2) MUAH-16 which is a medication adherence questionnaire for hypertension; and (3) pickups from pharmacies. The self-reported values are supposed to be collected every day. MUAH-16 is measured pre- and post- intervention.

BP is considered to be measured every month. There are automatic devices in every primary care center that people can go and measure their BP free of charge.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •aged 40-70 years old
  • •have hypertension diagnosis (i.e. ICD 10 codes from I10 to I16 in the person's medical history) for 1 year or more and have prescribed medications;
  • •not receiving medication with unit-dose packaged (Apodos);
  • •no previous stroke or myocardial infarction;
  • •no psychological disorder or cognitive impairment;
  • •no pregnancy-induced hypertension;
  • •no insulin treatment;
  • •no kidney disease defined as glomerular filtration rate (GFR) <60 ml/min

排除标准

  • •have no own smartphone
  • •not understanding the Swedish language both spoken and written

研究组 & 干预措施

adaptive intervention

Experimental

The patients will receive various adaptive digital interventions through mobile app.

干预措施: showing trends (Behavioral)

adaptive intervention

Experimental

The patients will receive various adaptive digital interventions through mobile app.

干预措施: Educational message (Behavioral)

adaptive intervention

Experimental

The patients will receive various adaptive digital interventions through mobile app.

干预措施: Motivational messages (Behavioral)

adaptive intervention

Experimental

The patients will receive various adaptive digital interventions through mobile app.

干预措施: Reminder (Behavioral)

结局指标

主要结局

change from baseline medication adherence score at 6 months

时间窗: 6 months

medication adherence score (MA) measured through the Maastricht Utrecht Adherence in Hypertension (MUAH-16) questionnaire. The higher score is correlated to better medication adherence. MUAH-16 has 4 subscales: 2 of them measures positive and the other 2 measures negative aspects of medication adherence. Therefore, we consider a positive score for the 2 positive subscales and negative scores to the negative ones. The result will be the final score showing the medication adherence score of the participant. The answers are supposed to be on a 7-point Likert scale (1: completely disagree and 7:completely agree). Therefore, the max score will be 48 and the min score will be -48. Based on the previous study, there has been shown a correlation between having a higher score and higher medication adherence.

次要结局

  • change from baseline health literacy score at 6 months(6 months)
  • change from baseline Blood pressure at 6 months(6 months)
  • change from baseline Quality of Life at 6 months(6 months)

研究者

发起方
Halmstad University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kobra Etminani

Assistant Professor at CAISR, department of ISDD, School of ITE, HH

Halmstad University

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