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临床试验/NCT06927271
NCT06927271招募中不适用

Effectiveness, Cost-effectiveness, and Acceptability of Phone Call and Video-based Interventions to Improve Adherence to Antihypertensive Medications

University of Ghana1 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2025年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,400
试验地点
1
主要终点
change in systolic blood pressure

研究概览

简要总结

The goal of this clinical trial is to find out if phone call and video-based interventions that seek to educate people with uncontrolled high blood pressure and also remind them to take their medicines will improve adherence to their medicines. It will also examine if the interventions are economical to implement. The main objectives of the study are:

  • Design videos and phone call-based interventions for people with hypertension.
  • Examine the effect of videos and phone call-based intervention on adherence to medication in people with hypertension.
  • Calculate the costs associated with the mobile health intervention
  • Examine the factors influencing acceptance of video and phone calls based interventions for improving adherence to antihypertensive medications among patients

Participants will:

  • Receive the intervention thrice weekly for 3 months
  • Visit the health facility at the end of 3 months for check up and measurement of outcome variables (adherence and blood pressure). Additionally, at the end of 3 months, the acceptability of the interventions will be measured among the participants who received either phone call or video.

Researchers will compare the two groups (one group will utilize phone call whereas the other videos) with the control group to see if the mobile interventions improve adherence to medicines. Only adults 18 years and above in selected health facilities in the Eastern will participate in the study. The selected participants should have uncontrolled blood pressure based on readings from last 2 visits. To be included in the study, the participants need to own a smartphone.

详细描述

Hypertension prevalence in adults ranges between 19 percent and 55 percent in Ghana (Agongo et al., 2020). About half of the patients diagnosed with hypertension in Ghana exhibit signs of organ damage which occur as a result of poor control of blood pressure and late detection by the health system (Atibila et al., 2021). Despite the availability of effective treatment regimen and evidence of benefits of treatment, hypertension remains poorly controlled in Ghana as studies have reported control rates ranging from 24 percent to 42 percent (Sanuade et al., 2018).

The high prevalence of uncontrolled blood pressure has been attributed mainly to poor medication adherence (Boima et al., 2015). A study conducted by Abeasi et al. (2022) in the Upper East region indicated that about 60 percent of hypertensive patients were nonadherent to their medications. Also, another study (Adomako et al., 2021) reported non-adherence rates of 49 percent and 53 percent in two hospitals in the Ashanti region. These high rates of nonadherence thwart the efforts to control and manage hypertension.

With the increase in availability and uptake of mobile phones worldwide, mobile health technologies (mHealth) have been identified as promising strategies that can be used to remind, motivate and educate patients about their disease as well as medications to improve adherence to medications in patients with hypertension (Anglada-Martinez et al., 2015; Xiong et al., 2018). Ghana has the highest mobile penetration rate in Africa (Global System for Mobile Communications Association (GSMA), 2020) and as of 2021, there were over 40 million mobile connections in the country (Kemp, 2021). The widespread use of mobile phones provides a unique opportunity for clinicians to leverage mHealth to improve medication adherence as they are incorporated widely into daily life.

Studies that have utilized mHealth interventions to improve adherence to antihypertensive medications have mostly employed short message service (SMS)(Buis et al., 2017; Leon et al., 2015; Maslakpak & Safaie, 2016; Sartori et al., 2020; Varleta et al., 2017). The challenge with text messaging or SMS is that it is difficult to apply to every context, especially in Africa where the literacy level is reported to be low (Gee et al., 2015). Also, evidence suggests that individuals with lower levels of education may not open and read the messages (Saleh et al., 2018). There is also the likelihood that people may read the messages and may not understand them (Sartori et al., 2020). Additionally, text messaging restricts the number of characters that can be sent and hence, messages sent may lack details which makes them difficult to be understood (Schoenthaler et al., 2020). Other authors have noted that the content of the messages may become monotonous resulting in message fatigue and possible withdrawal from the study (Finitsis et al., 2014; Horner et al., 2017).

Other equally important alternatives such as phone calls and videos can overcome most of the challenges associated with SMS (Asante et al., 2020; Stanczyk et al., 2016). Existing evidence from the healthcare literature suggests that videos perform better than written words since words cannot convey facial expressions and body language (Schooley et al., 2015). Again the use of videos is useful for individuals who have less education, health literacy and motivation to take medicines as it does not necessitate extensive reading of numerous pages of written material (Ben-Zeev et al., 2018). The use of phone call based interventions also increases patients confidence in the information provided and allows them to receive immediate feedback on queries about their illness or medications (Son et al., 2020). There is a paucity of studies on use of phone call and video-based interventions in improving adherence to medications in hypertensive patients in the mHealth literature (Chun-Yun Kang, 2022).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult aged 18 years or older
  • diagnosed of hypertension
  • has uncontrolled hypertension (i.e. systolic blood pressure ≥140 mmHg and a diastolic blood pressure ≥ 90mmHg) documented in their records on 2 clinic visits
  • has been prescribed at least one antihypertensive medication for a period of 2 months before the study
  • owns a smart phone or has access to one at all times.

排除标准

  • Pregnant women with hypertension or within 3 months postpartum
  • Hypertensive patients with diabetes, liver failure or kidney disease
  • Plans to travel out of the country during the period of the study
  • Participating in another mobile health intervention or medication adherence intervention
  • has a psychiatric disease or mental illness 6) has a visual impairment.

结局指标

主要结局

change in systolic blood pressure

时间窗: baseline and 3 months

The systolic blood pressure at baseline will be compared to the systolic pressure at endline. This will help to determine if the intervention has an effect on the blood pressure

Medication adherence measured using the Morisky Medication Adherence Scale-8(MMAS-8)

时间窗: baseline and 3 months

Medication adherence will be measured at baseline and then after administering the intervention. MMAS-8 has eight items on the scale. The first seven (7) items on the scale require a yes or no response whereas the eighth item uses a five-point Likert scale (never/rarely to all the time). The total score ranges from 0 to 8 with a score of \<6 indicative of non-adherence. A score between 6 \< 8 indicates medium adherence whereas a score of 8 shows high adherence.

次要结局

  • Proportion of patients with controlled blood pressure(baseline and 3 months)
  • Acceptability of the intervention(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GRACE ADJEI OKAI

Principal Investigator

University of Ghana

研究点 (1)

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