Hatzioannou Anna, Chatzittofis Andreas, Koutroubas Virginia Sunday, Papastavrou Evridiki, Karanikola Maria
Nursing Department, School of Health Sciences, Cyprus University of Technology, Limassol, Cyprus.
Medical School, University of Cyprus, Nicosia, Cyprus.
JMIR Res Protoc. 2021 Sep 8;10(9):e25168. doi: 10.2196/25168.
Addressing the enhancement of ill health self-management skills in adults diagnosed with bipolar disorder may be considered an important intervention for health care systems worldwide.
This protocol describes the study "Management of my Bipolarity" (MoB), which aims to develop an educational intervention for adults with bipolar disorder and assess its effectiveness. The objectives include (a) a literature review on bipolar disorder educational interventions; (b) a qualitative exploration of the educational needs of people with bipolar disorder; (c) development of an educational intervention based on objectives (a) and (b) (ie, the MoB educational intervention); and (d) exploration of the effectiveness of the intervention regarding participants' knowledge of their mental health condition and enhancement of their ill health self-management skills. The MoB educational intervention will consist of an in-person and a web-based intervention in the form of a digital platform.
The proposed interventional study is a combination of a qualitative and a quantitative design (mixed methods study). A focus group and content analysis will be implemented for the qualitative assessment of the educational needs of adults with bipolar disorder. The intervention will be developed based on the qualitative data of the study and relevant literature. The effectiveness of the acquired knowledge and self-management skills will be assessed according to (a) substance use behavior, (b) health locus of control, (c) impulse control, (d) adherence to pharmacotherapy, (e) relapse prevention, (f) improvement of quality of life, and (g) bipolar disorder knowledge level via structured instruments in the quantitative part of the study using descriptive and inferential statistics (SPSS version 24.0).
A total of 13 patients with bipolar disorder have been interviewed (8 women, 5 men) to identify educational needs to be covered through the intervention. Moreover, a literature review on bipolar disorder educational interventions has been completed. These data have been incorporated in the design of the MoB in-person intervention and the digital platform. The digital platform is live, and the development of the MoB in-person intervention was completed at the end of 2020. The recruitment of the participants for the intervention (40 patients) and the control group (40 patients) began during the first semester of 2021. Moreover, by tracking the platform for 1.5 years, we have recorded that 2180 users have visited the platform with an average session duration of almost 2 minutes. Mobile and tablet devices are being used by 70% of the visitors.
Since new parameters regarding educational interventions will be explored, these findings are expected to provide evidence that participation in structured educational interventions offers patients the opportunity to improve adherence to pharmacotherapy and increase their quality of life.
ClinicalTrials.gov NCT04643210; https://clinicaltrials.gov/ct2/show/NCT04643210.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25168.
提高被诊断为双相情感障碍的成年人的健康自我管理技能,可能被视为全球医疗保健系统的一项重要干预措施。
本方案描述了“我的双相情感障碍管理”(MoB)研究,旨在为双相情感障碍成年人开发一种教育干预措施并评估其有效性。目标包括:(a)对双相情感障碍教育干预措施进行文献综述;(b)对双相情感障碍患者的教育需求进行定性探索;(c)基于目标(a)和(b)开发一种教育干预措施(即MoB教育干预措施);(d)探索该干预措施在参与者对其心理健康状况的了解以及增强其健康自我管理技能方面的有效性。MoB教育干预措施将包括以数字平台形式进行的面对面干预和基于网络的干预。
拟进行的干预性研究采用定性和定量设计相结合的方式(混合方法研究)。将实施焦点小组和内容分析,以对双相情感障碍成年人的教育需求进行定性评估。将根据该研究的定性数据和相关文献来开发干预措施。将在研究的定量部分,通过结构化工具,依据(a)物质使用行为、(b)健康控制点、(c)冲动控制、(d)药物治疗依从性、(e)预防复发、(f)生活质量改善情况以及(g)双相情感障碍知识水平,使用描述性和推断性统计(SPSS 24.0版)来评估所获得的知识和自我管理技能的有效性。
共访谈了13名双相情感障碍患者(8名女性,5名男性),以确定干预措施应涵盖的教育需求。此外,已完成对双相情感障碍教育干预措施的文献综述。这些数据已纳入MoB面对面干预和数字平台的设计中。数字平台已上线运行,MoB面对面干预的开发于202年年底完成。2021年第一学期开始招募干预组(40名患者)和对照组(40名患者)的参与者。此外,通过对该平台进行1.5年的跟踪,我们记录到有2180名用户访问过该平台,平均会话时长近2分钟。70%的访问者使用移动和平板设备。
由于将探索有关教育干预措施的新参数,预计这些结果将提供证据,表明参与结构化教育干预措施为患者提供了改善药物治疗依从性和提高生活质量的机会。
ClinicalTrials.gov NCT04643210;https://clinicaltrials.gov/ct2/show/NCT04643210。
国际注册报告识别码(IRRID):DERR1-10.2196/25168。