跳至主要内容
临床试验/NCT04643210
NCT04643210Unknown不适用

The Management of My Bipolarity Intervention on the Combined Use of Technology and Face to Face Education on the Empowerment of Ill Health Self-management Skills in Adults With a Bipolar Disorder

Cyprus University of Technology1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Degree of adherence to pharmacotherapy, as measured by the total score in the scale "Drug Attitude Inventory" (DAI).

研究概览

简要总结

The Management of my Bipolarity study aims to develop an educational intervention (MoB EI) on the combined use of technology and face to face education on the empowerment of ill health self-management skills in adults with bipolar disorder. The MoB EI will be developed according to qualitative data on patients' educational needs and relevant literature. The effectiveness of acquired knowledge and self-management skills will be assessed according to the degree of a) cognitive functioning, b) impulse control, c) adherence to pharmacotherapy, d) relapse prevention, d) improvement of quality of life of participants.

详细描述

The aim of the study is to develop and test an educational intervention for patients with bipolar disorder (BD). The objectives include:

  1. A literature review on BD educational programs.
  2. Exploration of the educational needs of adults with BD.
  3. Development of the MoB educational intervention (MoB EI), encompassing a face to face (F2F) intervention and a technology-based intervention via a Digital platform (MoB DP).
  4. Exploration of the effectiveness of the MoB EI in BD patients regarding i) their knowledge on BD, and ii) empowerment of ill health self-management skills in relation to the improvement of impulse control, adherence to pharmacotherapy, relapse frequency, quality of life and adaptive attitudes towards substance use.

Design This study uses a mixed-method design and consists of four stages.

Stage 1: (a) To conduct a literature review on BD educational programs, and (b) define the educational needs of adults with BD via empirical exploration of their living experience (a focus group and content analysis will be implemented for this qualitative assessment), aiming to integrate both data in the MoB EI.

Stage 2: Design of the MoB F2F EI & the MoB Digital Platform (MoB DP). ΜoΒ F2F EI:The design of this intervention will rely on the Colom & Vieta model, Cognitive- Behavioural techniques and the results of the 1st stage (all relevant literature and data acquired in the qualitative research of educational needs). A textbook will be devised explaining in detail the step-by-step process and the techniques of the experimental educational method of the MoB F2F EI.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •Clinical diagnosis based on DSM-5 for BD type I and II.
  • •Age between 18 and
  • •Signed informed consent.
  • •Stabilized mood status at the beginning of the MoB F2F intervention based on clinical assessment, conducted by the primary investigator (AH).
  • •Experience of the illness of at least one year based on reported medical record.
  • •Adequate awareness of the illness, based on the following guide: (a) are you aware of the reason(s) you are using mental health services/ under medication? and (b) are you aware of the aim of the educational intervention in which you may participate?

排除标准

  • •Intellectual disability (IQ<70), based on the Wechsler Adult Intelligence Scale (WAIS).
  • •Brain damage (e.g, following a stroke), based on diagnostic tests.
  • •Acute phase of the illness which requires hospitalization.
  • •Acute phase of the illness, based on clinical assessment, as well as the Young Mania Rating Scale (YMRS) and/or Beck's Depression Inventory (BDI) tools.
  • •Substance use problems at the beginning of this stage according to the Alcohol Use Disorders Identification Test (AUDIT) and Drug Use Disorders Identification Test (DUDIT) tools.

研究组 & 干预措施

F2F MoB EI and access to MoB Digital Platform (MoB DP) group

Experimental

The design of the face-to-face Management of my Bipolarity educational intervention (F2F MoB EI) will rely on the Colom & Vieta model, Cognitive- Behavioural techniques and the results of the relevant literature review and data acquired in the qualitative research of bipolar disease patients' educational needs. A textbook will be devised explaining in detail the step-by-step process and the techniques of the experimental educational method of the MoB F2F EI.

This group will also receive the technology-based intervetion, which regards access to the MoB DP. This is an ecosystem where the participants will be educated and empowered making use of the internet of things (IOT) via a computer, tablet or mobile.

干预措施: MoB DP (Other)

F2F MoB EI and access to MoB Digital Platform (MoB DP) group

Experimental

The design of the face-to-face Management of my Bipolarity educational intervention (F2F MoB EI) will rely on the Colom & Vieta model, Cognitive- Behavioural techniques and the results of the relevant literature review and data acquired in the qualitative research of bipolar disease patients' educational needs. A textbook will be devised explaining in detail the step-by-step process and the techniques of the experimental educational method of the MoB F2F EI.

This group will also receive the technology-based intervetion, which regards access to the MoB DP. This is an ecosystem where the participants will be educated and empowered making use of the internet of things (IOT) via a computer, tablet or mobile.

干预措施: F2F MoB EI (Behavioral)

The MoB DP group

Active Comparator

This group will receive the technology-based intervention, which regards access to the MoB DP. The structure of the MoB DP has been partially based on the preferences and needs of the participants (as described in the qualitative part of the study) and its goal is to create an ecosystem where users will be educated and empowered making use of the internet of things (IOT) via a computer, tablet or mobile. The Digital platform will be in the form of a dynamic website with user generated content as well as static information.

干预措施: MoB DP (Other)

结局指标

主要结局

Degree of adherence to pharmacotherapy, as measured by the total score in the scale "Drug Attitude Inventory" (DAI).

时间窗: 18 months

The "DAI" is a 30 item "true-false" scale.The ration of "true" to "false" responses is assessed. Higher percentage values indicate a better outcome.

Degree of feasibility of the digital platform, as measured by users' qualitative feedback on the following open-ended question: "Please tell us, what was your experience with the MoB DP use?

时间窗: 6 months

The more positive the described experience the better the outcome.

Bipolar disease patients educational needs

时间窗: 6 months

Qualitative measures: 1. Knowledge/ mental health literacy on present medical condition (measurement tool \[MT\]/ Open-ended question: Please tell us, what do you know about your mental health condition/ BD?) 2. Knowledge gap regarding BD (MT/ Open ended question: Please describe what you would like to know about bipolar disorders). 3. Topics to be covered (MT/ Open ended question: Please describe in what way/topics you would like to be educated on bipolar disorders/to increase your knowledge about bipolar disorders? 4. Educational and feasibility expectations (MT/ Open-ended questions: a. Please describe your expectations from an educational program regarding the impact on your everyday living b. How you would like this program to be implemented one on one or in a group? C. How long would you like the program to last? 5. e-Health literacy (MT/ Open ended question: What is your level of engagement with the Internet?)

Degree of self-perceived quality of life as measured by the total score in the scale "World Health Organization Quality of Life Assessment".

时间窗: 18 months

The scale "World Health Organization Quality of Life Assessment" is a 1-5 Likert type scale including 26 items. The minimum score in the scale is 26 and the maximun is 130. Higher scores indicate a better outcome.

Level of knowledge regarding BD, as measured by the total score in the scale "Bipolar Disorder Knowledge Scale".

时间窗: 18 months

The "Bipolar Disorder Knowledge Scale" is a 25-item true-false scale. The scale assesses knowledge of BD with items targeting diagnosis, etiology, disease course, symptoms, treatment, and life impact. The ration of "true" to "false" responses is assessed. Higher percentage values indicate a better outcome.

Degree of ability to control impulses, as measured by the total score in the scale "YOUNG MANIA RATING SCALE " (YMRS) .

时间窗: 18 months

The "YMRS" is a 0-4 likert scale, including 11 items. The total score of the scale ranges from 0 to 44. The lower the total score the better the outcome.

Degree of feasibility of the digital platform, as measured by the users' qualitative feedback on the impact of the MoB DP on their life based on the following open-ended question: "Please tell us, what was the impact of the MoB DP use on your life?"

时间窗: 6 months

The more positive the described impact of the MoB DP on users' life the better the outcome.

Degree of dysfunctional attitudes towards substance use as measured by the total score in the scale "Drug Use Disorders Identification Test" (DUDIT).

时间窗: 18 months

The scale DUDIT is a 1-5 Likert, 11-item scale (scale total score range: 1-55) . The lower the total score the better the outcome. Lower scores indicate a better outcome.

Degree of dysfunctional attitudes towards alcohol as measured by the total score in the scale "Alcohol Use Disorders Identification Test" (AUDIT).

时间窗: 18 months

The AUDIT scale is a 0-4 Likert, 10-item scale (scale total score range: 0-40) . Lower scores indicate a better outcome.

Frequency of relapses, as measured by the number of hospitalizations after the completion of the face to face intervention.

时间窗: Two years following the end of the face tot face educational intervention.

The number of hospitalizations will be measured as the sum of the individual hospitalizations in a high security psychaitric hospital. The lower the number of the frequency the better the outcome.

Reduced duration of relapses, as measured by the duration of inpatient hospitalizations in days after the completion of the face to face intervention.

时间窗: Two years following the end of the face to face educational intervention.

The duration of inpatient hospitalizations will be measured as the sum of the days of hospitalization in high security psychaitric hospitals. The lower the duration in days of the hospitalization the better the outcome.

Degree of feasibility of the digital platform, measured by users' feedback on the impact of the platform on their self-management skills based on the question "What was the impact of the platform on your ill health self-management skills?"

时间窗: 6 months

The more positive the described impact of the digital platform on users' ill health self-management skills the better the outcome.

Degree of feasibility of the digital platform, as measured by users' self-reported degree of satisfaction on MoB DP by the total score on the scale "Users' Satisfaction Scale" (USS).

时间窗: 6 months

The USS is 1-3 Likert scale (low;moderate/accepted; high), which includes 6 items, assessing users' perceptions about overall experienced satisfaction (item1); utility according to their present medical condition (item 2); feasibility on daily usage (item 3); technical difficulties experienced (item 4); improvement of BD self-management skills (item 5); improvement of BD knowledge (item 6). The total score of the USS ranges between 6- 18. The higher the total score the better the outcome.

次要结局

  • Description of the topics of the MoB educational intervention through a qualitative measure.(6 months)
  • Description of the different modes of the MoB educational intervention through a qualitative measure.(6 months)
  • Description of the mode of the MoB educational intervention through a qualitative measure.(6 months)
  • Description of the MoB DP technology-based intervention through a qualitative measure.(6 months)

研究者

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

Maria Karanikola

Accosiate Professor

Cyprus University of Technology

研究点 (1)

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