Clinical trial NCT04643210: Management of my Bipolarity Intervention in Bipolar Disorder Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Affective Psychosis, Bipolar
Manic-Depressive Psychosis
Depression, Bipolar
Keywords: Education
Empowerment
Bipolar Disorder
Self-management
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a combination of a qualitative and a quantitative, interventional (quasi experimental) design. A focus group and content analysis will be implemented for the qualitative assessment of the educational needs of adults with a bipolar disorder. The educational intervention (MoB EI) will be developed according to the qualitative data on patients' educational needs and relevant literature, aiming to include combination of face to face (F2F) and technology-based interventions via design of a Digital platform. The effectiveness of the MoB EI regarding the acquired self-management skill will be assessed via structured instruments in the quantitative part of the study using descriptive and inferential statistics (SPSS version 24.0).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

MoB DP: The structure of the MoB DP has been designed by the researchers of the present study and a web developer, partially based on the preferences and needs of the participants (as described in Stage 1); its goal is to create an ecosystem where people with BD will be educated and empowered making use of the internet of things (IOT) via a computer, tablet or mobile. The MoB DP will be in the form of a dynamic website with user generated content as well as static information. A responsive design has been applied, i.e. accessible by all types of devices. The platform is accessible to the participants in the current study, as well as to any interested person, e.g., family members of people with BP, or care givers providing updated information related to BD (platform users). The platform administrator is the main researcher (AH), while the owner is the Nursing Department of the Cyprus University of Technology (CUT). The participants of the proposed study will have the opportunity to access the platform both during and after the completion of the study.

The informative part of the platform is live (www.mob.com.cy), while the interactive part is under development. The informative part, so far, includes the following functionalities: self-management action plan, home-work exercises, self-assessment tools, scientific articles relevant to BD. Entry into the platform functionalities (scientific articles excluded) is password protected.

Specifically, the users of the platform will have the opportunity to register by filling in their personal profile and revisit when they wish. Regarding self-management functionalities, the platform will contain subject units where personal relapse symptoms may be registered, a life events table, personal risk factors for relapse and a weekly program of activities. Input of relevant information will be through open-ended questions and check lists. Participants of the MoB F2F EI who visit the platform, will find that these subject units (chapters) are topics on which they will be educated on. Additional features will be incorporated according to development of 1st stage, e.g., new training needs, as described by participants in the focus groups.

Another subject unit will be the personal therapy file, where users will have the chance to keep tabulated notes related to their therapy, including information about the dose and type of medication treatment, as well as pending medical test, e.g., blood test, and other relevant information. The therapeutic team of the user will have the possibility to register in the platform under the approval of the user with the aim to support continuity and sharing of information.

Stage 3: Implementation and evaluation of the effectiveness of the MoB EI. All eligible participants will be assigned into the intervention group and the control group. Based on power analysis the intervention group will be constituted of 40 participants and the control (waiting) group of 40 participants.

The criteria for discontinuing participation in intervention group are disorder relapse and non-adherence to pharmacotherapy (discontinuation of medication).

Intervention description. The intervention group will receive the MoB F2F EI on group or personal form according to the participant's choice. Also the participants of the intervention group will have access to the MoB DP.

The implementation methodology of the MoB F2F EI will include videos and power point presentations, as well as interactive learning methods such as role-playing, empowerment exercises, live discussions.

The MoB F2F EI will comprise a total of 12 educational F2F sessions. Each session will have a duration of 1.5 hours and the maximum number of participants in the groups will be 12 patients. At the beginning of each session, the participants will be given the opportunity to record their feedback for the previous session and the impact of the training program, so far, on them and their families / significant others. The location where the MoB F2F EI will be conducted is the CUT. The main researcher (AH) will implement the MoB F2F EI. Participation in the educational intervention is free of charge. Also, no economic outcomes are expected to emerge through this or any stage of the study.

Those who will wish to withdraw before completion of the intervention, will be able to continue to receive information/knowledge about their illness through the digital platform.

The control group will have access only to the MoB DP.

Effectiveness evaluation. The evaluation of the effectiveness of the MoB F2F EI will be based on the degree of improvement on the following parameters:

1. Self-perceived quality of life level
2. Ability to control impulses
3. Psychoactive substances use attitudes
4. Adherence to pharmacotherapy
5. Frequency of relapses
6. BD Knowledge level

There will be four evaluation timepoints. The 1st evaluation timepoint will be prior to the implementation of the MoB F2F EI, the 2nd will take place immediately after the completion of the MoB F2F EI, while the 3rd and 4th ones will be applied six and twelve months, respectively, after the completion of the MoB EI. These timepoints have been determined according to relevant literature.

The control group will be assessed via the same evaluation tools as the intervention group, and at the same time periods.

This will verify the hypothesis that patients who receive only pharmacotherapy and have access to the MoB DP do not have the same improvement as intervention group in important aspects of their lives, i.e., quality of life, cognitive functioning, impulse control, adherence to pharmacotherapy, relapse prevention.

Data analysis. Mean and standard deviation will be assessed for the scale numeric scores (WHOQOL, DUDIT, MoCa, DAI-30, relapse frequency) and frequencies will be tested for categorical variables (gender, age groups, group years in illness). Parametric tests (ANOVA, t-test) will be applied for comparisons between groups. For all statistical tests, p values of 0.05 or lower will be considered statistically significant. Data will be analysed through the Statistical Package for Social Sciences (SPSS, Inc, Chicago, IL version 25.00). To test the relationship between two or more variables logistic and linear regression analysis will be used. Regarding missing data, multiple imputation method will be applied.

Stage 4: Assessment of the applicability of the Digital platform. The assessment of the applicability of the digital platform will be based on qualitative (users' feedback) and quantitative testing (data analysis). Regarding users' qualitative feedback, there will be an exploration of the experience of the users with the platform and the degree to which they were positively affected by its use. This process will take place via focus groups discussions. The focus of the interviews will be on the impact of the platform on their everyday life, as well as on enhancement of ill health self-management skills. It is intended to deliver 2 focus groups with 8-12 participants each. The participants will be among those who (a) attended the F2F EI and at the same time had used the platform, (b) only had access to the MoB DP.

The evaluation of the platform will also take place through anonymous questionnaires by asking the users of the platform to answer predefined questions regarding satisfaction parameters relevant to the platform. The technology which will be applied for this process is Google Forms. This part of the assessment is expected to take place during the second half of 2021.

Eligibility criteria: Inclusion criteria:

1. Clinical diagnosis based on DSM-5 for BD type I and II.
2. Age between 18 and 65.
3. Signed informed consent.
4. Stabilized mood status at the beginning of the MoB F2F intervention based on clinical assessment, conducted by the primary investigator (AH).
5. Experience of the illness of at least one year based on reported medical record.
6. 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?

Exclusion criteria:

1. Intellectual disability (IQ\<70), based on the Wechsler Adult Intelligence Scale (WAIS).
2. Brain damage (e.g, following a stroke), based on diagnostic tests.
3. Acute phase of the illness which requires hospitalization.
4. 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.
5. 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.

Primary outcomes:
measure: Bipolar disease patients educational needs
timeFrame: 6 months
measure: Degree of self-perceived quality of life as measured by the total score in the scale "World Health Organization Quality of Life Assessment".
timeFrame: 18 months
measure: Level of knowledge regarding BD, as measured by the total score in the scale "Bipolar Disorder Knowledge Scale".
timeFrame: 18 months
measure: Degree of ability to control impulses, as measured by the total score in the scale "YOUNG MANIA RATING SCALE " (YMRS) .
timeFrame: 18 months
measure: Degree of adherence to pharmacotherapy, as measured by the total score in the scale "Drug Attitude Inventory" (DAI).
timeFrame: 18 months
measure: Degree of dysfunctional attitudes towards substance use as measured by the total score in the scale "Drug Use Disorders Identification Test" (DUDIT).
timeFrame: 18 months
measure: Degree of dysfunctional attitudes towards alcohol as measured by the total score in the scale "Alcohol Use Disorders Identification Test" (AUDIT).
timeFrame: 18 months
measure: Frequency of relapses, as measured by the number of hospitalizations after the completion of the face to face intervention.
timeFrame: Two years following the end of the face tot face educational intervention.
measure: Reduced duration of relapses, as measured by the duration of inpatient hospitalizations in days after the completion of the face to face intervention.
timeFrame: Two years following the end of the face to face educational intervention.
measure: 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?
timeFrame: 6 months
measure: 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?"
timeFrame: 6 months
measure: 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?"
timeFrame: 6 months
measure: 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).
timeFrame: 6 months
Secondary outcomes:
measure: Description of the topics of the MoB educational intervention through a qualitative measure.
timeFrame: 6 months
measure: Description of the mode of the MoB educational intervention through a qualitative measure.
timeFrame: 6 months
measure: Description of the different modes of the MoB educational intervention through a qualitative measure.
timeFrame: 6 months
measure: Description of the MoB DP technology-based intervention through a qualitative measure.
timeFrame: 6 months
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: Cyprus University of Technology
Study officials:
affiliation: Cyprus University of Technology
name: Maria NK Karanikola
role: STUDY_CHAIR
References:
citation: 21. Hatzioannou A, Papastavrou E, Chatzittofis A, Karanikola M. Exploration of the effectiveness of structured education in empowering people with Bipolar Disorder. Nursing Care & Research 2020;55:246-274.
citation: Hatzioannou A, Chatzittofis A, Koutroubas VS, Papastavrou E, Karanikola M. Combined Use of Web-Based and In-Person Education on Ill Health Self-management Skills in Adults With Bipolar Disorder: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Sep 8;10(9):e25168. doi: 10.2196/25168.