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Design
A user-centered and iterative approach was adopted in the development of E-nergEYEze and applied during all stages of this pilot study. A usability study was conducted to evaluate and optimize usability, using qualitative methodology. Subsequently, potential effectiveness, feasibility of study methods and fidelity to t...
PMC10655361
Intervention development
fatigue, visual impairment
LOW VISION
E-nergEYEze was developed by a design team represented by patients with visual impairment (n = 3), social workers (n = 2), psychologists (n = 3), information and communication technology (ICT) trainers (n = 2) of two large low vision service organizations in the Netherlands (i.e. Royal Dutch Visio and Bartiméus), and r...
PMC10655361
Recruitment
fatigue, visual impairment, Fatigue
LOW VISION
Participants were recruited through purposive sampling by social workers from the two low vision service organizations in the Netherlands between October 2019 and June 2020. Inclusion criteria for the usability study were: (a) having an ophthalmic visual impairment (visual acuity ≤ 6/18 and/or ≤ 30 degrees concentric v...
PMC10655361
Procedure usability study
visual impairment
Usability was evaluated by five participants with visual impairment (Table 
PMC10655361
Ethics
The pilot study was approved by the Medical Ethics Committee of Amsterdam University Medical Centers, location VU Medical Centre in Amsterdam. All participants gave written informed consent prior to participation and where enrolled by the executive researcher. Taking into account the vulnerabilities and capacities of t...
PMC10655361
Outcome measure
fatigue, Fatigue
The primary outcome was fatigue severity measured with the CIS-FS. Fatigue severity is a subscale of 8 items, ranging from 8 to 57 points with ≥ 35 points indicating severe fatigue and is considered a valid and reliable tool [
PMC10655361
Qualitative analysis usability study
Data from the usability study were qualitatively analyzed using an inductive approach. Relevant information of the recorded files were transcribed, after which data was organized to show and interpret patterns for recurrent themes by the executive researcher [
PMC10655361
Statistical analysis feasibility study
SECONDARY
Data from the feasibility study were converted from Castor to the statistical software package SPSS for Windows version 26 (SPSS IBM, New York, USA). Quantitative data were analyzed using descriptive statistics and qualitative data were analyzed by the executive researcher using a thematic approach. In addition, user l...
PMC10655361
Results
PMC10655361
Usability study
Most participants (4/5) used assistive technology (e.g. screen reader and/or screen magnifier). Overall, participants would recommend the intervention to others (4/5) and were personally interested in following the intervention (3/5). Thematic analysis of the think aloud method and semi-structured interviews resulted i...
PMC10655361
Digital challenges
Participants reported a lack of clarity on how to use the e-platform and follow the modules: the meaning of e-platform buttons were unclear (4/5), entering an answer by typing was difficult (4/5), it was difficult to activate the e-platform account at the start (3/5), it was unclear how to navigate through the e-platfo...
PMC10655361
Lay-out
Participants noted several inconveniencies and obscurities regarding the lay-out. Most importantly, it was difficult to obtain an overview of the overall text (4/5), big pictures had no added value (4/5), text that was put in colored text areas gave insufficient contrast (3/5), read aloud audio had a small play button ...
PMC10655361
Content
Participants gave feedback regarding the module content: it was unclear that read aloud audio and written text contained the same information (4/5) and that there were assignments at the bottom of a page (4/5), it was confusing that there were multiple read aloud audio’s on one page (3/5), it was difficult to follow th...
PMC10655361
Improvements
meaning)-, training:-
Based on these results, we made user-specific improvements to E-nergEYEze, presented in Table  Results qualitative analysis usability study1. Mandatory computer training:- Assistance with registration in the e-platform- Instruction on e-platform features (location buttons and their meaning)- Instruction on how to navig...
PMC10655361
Feasibility study
The feasibility study was conducted during the COVID-19 pandemic, resulting in digital face-to-face sessions between participants and social workers at the start of the intervention. All participants opted for the visual version of the intervention. One participant initially preferred the non-visual version, but switch...
PMC10655361
Process evaluation participants – MHT questionnaire
Participants received sufficient information about the intervention (7/7) and on the expected outcome of the intervention (6/7). All participants experienced sufficient expertise, trust and respect from the social workers. They felt the content and guidance of E-nergEYEze was the right approach for their problems or co...
PMC10655361
Accessibility
POSITIVE
The participants mentioned difficulties scrolling up and down through a page (2/7), navigating (1/7), with the unchangeable contrast (1/7) and the voice-over not being accessible enough when using the application on a mobile phone (1/7). Positive comments were the optically short sentences (1/7), the presence of videos...
PMC10655361
Content
Participants reported that the expectation of the module content should be discussed in advance (3/7), as well as the type of assignments (1/7) and estimated time investment (3/7). One participant had hoped for more concrete, practical tools, instead of a main focus on mindset. On the other hand, participants mentioned...
PMC10655361
Guidance
Participants were positive about the overall guidance (7/7). The social workers were pleasant during contact moments, took time to answer questions and provided feedback with sufficient depth. One of the participants preferred more intense contact with regard to the module content. Participant experiences feasibility s...
PMC10655361
E-platform user login history
The seven participants who followed E-nergEYEze spent a median of 11.5 weeks (range 6–15) on completing four modules. One participant exceeded the time period of three months and explained that she wanted to do really well in the module on work participation that took a little longer. The number of times logged into th...
PMC10655361
Therapist process evaluation
All social workers (5/5) were satisfied with the face-to-face sessions and according to them most participants (4/7) gave sufficiently detailed answers to the assignments. Three participants gave answers that varied in comprehensiveness or were insufficient. The digital aspect of providing written feedback went well fo...
PMC10655361
Discussion
fatigue, visual impairment
The main focus of this pilot study was to evaluate and optimize E-nergEYEze, an E-health intervention to reduce fatigue in adults with visual impairment. The usability study resulted in adjustments based on participants’ feedback on the content and lay-out of E-nergEYEze. Digital challenges for people with visual impai...
PMC10655361
Acknowledgements
DER
We would like to thank our intervention design team members: Nelleke Schoenmakers, Marjolein van Keulen, Corine Blonk, Margreet de Vries, Sylvia van der Sluis, Petra Colen, Joke de Jager, Erna Luttik, Mark van Wijnhoven, Evert Veldman, Kirsten Veldhoen, Mirjam te Brake, Wim Grooten and Ger Klein.
PMC10655361
Authors’ contributions
MH
RvN and HvdA conceived the study and its design. GvR, HK, CB and CH advised in the development of the design. LvdH contributed to the acquisition of data and MH contributed to the statistical analysis of data. MV collected the data, performed the analyses and drafted the manuscript, which was revised by the other autho...
PMC10655361
Funding
This study was externally funded and supported by the Dutch Organization for Health Research and Development (“ZonMw program Inzicht”, grant No 60-00635-98-219).The sponsor has no role in the design and conduct of the study or in the writing of the manuscript and will not have any role during its execution, analyses, i...
PMC10655361
Data availability
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC10655361
Declarations
PMC10655361
Ethics approval and consent to participate
injury or death
This study protocol has been reviewed and approved by the Medical Ethical Committee of the VU University Medical Centre Amsterdam, the Netherlands (reference no. 2019/027, NL67802.029.18). The trial will be conducted according to the principles of the Declaration of Helsinki (seventh revision 2013), the Medical Researc...
PMC10655361
Consent for publication
Not applicable.
PMC10655361
Competing interests
The authors declare no competing interests.
PMC10655361
Abbreviations
VIRUS DISEASE
Cognitive Behavioral TherapySelf-ManagementInformation and Communication TechnologyE-health platformChecklist Individual Strength – subscale Fatigue SeverityCorona Virus Disease 2019 caused by SARS-CoV-2Baseline assessmentCompetencies of Cognitive Therapy Scale – Self ReportPunctate Inner ChoroidopathyRetinis Pigmentos...
PMC10655361
References
PMC10655361
Purpose
To compare Aevidum’s school mental health curriculum vs the curriculum plus Aevidum clubs in a mixed-methods study including pre/post surveys, a randomized clinical trial, and qualitative interviews.
PMC10748452
Design
Concurrent mixed-methods: Aim 1) pre-post surveys evaluated curriculum only vs curriculum plus club schools separately regarding changes in knowledge, help-seeking, and school culture; Aim 2) randomized clinical trial compared curriculum only to curriculum plus club schools; Aim 3) qualitative school staff interviews e...
PMC10748452
Setting
Curriculum delivered to 9th graders at ten Pennsylvania high schools; 5 schools randomized to start clubs.
PMC10748452
Subjects
Students (surveys), staff (interviews).
PMC10748452
Intervention
Aevidum curriculum plus/minus club.
PMC10748452
Measures
REGRESSION
Aim 1, mixed effects linear and logistic regression models for longitudinal data were used to analyze survey items at each time point. Aim 2, the same regression models were used, except models included a fixed-effect for group and group by time interaction effect. Aim 3, interviews were transcribed; a codebook was dev...
PMC10748452
Results
depression
Pre-survey 2557 respondents; 49% female, 86% non-Hispanic white. Post-survey 737 (29% response rate). Aim 1, pre-post (Likert responses, larger numbers favorable) demonstrated increased student knowledge to identify depression (4.26 [4.19-4.33] to 4.59 [4.47-4.71],
PMC10748452
Conclusions
Aevidum’s curriculum improved mental health knowledge and help-seeking; adding the club did not significantly change responses. Staff identified positive school culture impacts. Limitations include the lower post-survey response.
PMC10748452
Purpose
depressive, Depression
Less than half of United States adolescents experiencing a major depressive episode received treatment in 2020.The University of Michigan’s (UM) Peer-2-Peer (P2P) Depression Awareness Program was 1 such school-based initiative that aimed to decrease mental illness and promote well-being.Similar to P2P, Aevidum, meaning...
PMC10748452
Aevidum Curriculum and Clubs
The Aevidum Mental Health & Suicide Prevention Curriculum was developed with a team of school counselors, principals, and psychologists and consists of 5 lessons delivered over 3 hours.The Aevidum club can be implemented independently of the curriculum. The intent is to foster cultures of caring, kindness, and advocacy...
PMC10748452
Methods
PMC10748452
Design & Sample
This study took place over the August 2021–June 2022 school year and focused on evaluating Aevidum curriculum and club effectiveness to improve adolescent mental health knowledge, help-seeking intentions, and school culture. Overview of the components of the mixed-methods study.CONSORT flow diagram.
PMC10748452
Measures
Depression
Pre-post surveys, used with permission, were those used to evaluate P2P, the UM Depression Center P2P Depression Awareness Assessment.
PMC10748452
Qualitative Component
MAY
Survey responses from curriculum only schools were compared to curriculum plus club schools to understand the added benefit of the club on school culture. However, as school culture shifts may be subtle, the student survey data was supplemented with school staff interviews to better understand school culture outcomes f...
PMC10748452
Analysis
PMC10748452
Pre- and Post-Surveys
help-seeking behavior
REGRESSION, SECONDARY
In primary statistical analysis (Aim 1), curriculum only and curriculum plus club schools were analyzed separately, using the same methods. Mixed effects linear and logistic regression models appropriate for longitudinal (repeated measures) data were used to analyze all survey items collected at each time point. The mo...
PMC10748452
School Staff Semi-Structured Interviews
In Aim 3, the intent was to evaluate school culture change outcomes (eg, stigma) as a result of Aevidum. An inductive, qualitative codebook was developed by the study team after reviewing all transcripts and coming to consensus on common codes and sub-codes. Two independent coders (HC & ML) coded 20% of the data and me...
PMC10748452
Results
PMC10748452
Curriculum Only vs Curriculum Plus Club (Aim 2)
depression
Comparison of responses from curriculum only to curriculum plus club schools yielded essentially no differences in pre-post test responses between groups as relates to knowledge, except those in the curriculum only arm had significantly greater odds of recognizing that feeling tired or less energetic could be a symptom...
PMC10748452
Discussion
help-seeking behavior, depression
This mixed-methods evaluation of Aevidum’s mental health curriculum and club was undertaken to evaluate benefits for knowledge, help-seeking, and school culture. Ninth graders who received the curriculum and other students in the school demonstrated both improved mental health knowledge and help-seeking intentions (Aim...
PMC10748452
Comparison to Prior Research
depression, Depression
Findings are similar to those from to P2P.Similar results are reported from other school-based depression curricula. The Adolescent Depression Awareness Program (ADAP) was a three-hour curriculum delivered to 710 high school students from 6 Oklahoma schools. ADAP demonstrated improved knowledge and help-seeking, but on...
PMC10748452
Implications and Next Steps
depression
This study contributes to the growing body of literature on school-based depression education and peer support programming. Future investigations should consider the long-term impact of the curriculum, especially sustained changes in knowledge and help-seeking with annual exposure (Aim 1). Response rates may be improve...
PMC10748452
SO WHAT?
PMC10748452
What is already known on this topic?
depression
Research on school-based depression education and peer support programs demonstrates improved knowledge and help-seeking. Impact on school culture and reducing stigma is mixed.
PMC10748452
What does this article add?
The Aevidum curriculum and club are in widespread use, but lack formal evaluation of impacts on knowledge, help-seeking, and culture change. This evaluation considered Aevidum curriculum and club components, and added school staff perspective to better understand school culture outcomes.
PMC10748452
Ethical Statement
PMC10748452
Ethical Approval
The Penn State College of Medicine Institutional Review Board determined the STUDY00017706 to meet the criteria for exempt research.
PMC10748452
ORCID iD
Deepa L Sekhar
PMC10748452
References
PMC10748452
Background
High-grade glioma, HGG, debilitating disease
HIGH-GRADE GLIOMA
High-grade glioma (HGG) is a rapidly progressing and debilitating disease. Family carers take on multiple responsibilities and experience high levels of distress. We aimed to deliver a nurse-led intervention (Care-IS) to carers to improve their preparedness to care and reduce distress.
PMC9992082
Methods
HGG, depression, anxiety
We conducted a randomised controlled trial (ACTRN:12612001147875). Carers of HGG patients were recruited during patients’ combined chemoradiation treatment. The complex intervention comprised four components: (1) initial telephone assessment of carer unmet needs; (2) tailored hard-copy resource folder; (3) home visit; ...
PMC9992082
Results
SECONDARY
We randomised 188 carers (n = 98 intervention, n = 90 control). The intervention group reported significantly higher preparedness for caregiving at 4 months (model β = 2.85, 95% CI 0.76–4.93) and all follow-up timepoints including 12 months (model β = 4.35, 95% CI 2.08–6.62), compared to the control group. However, the...
PMC9992082
Conclusions
HGG
This intervention was effective in improving carer preparedness. However, carer distress was not reduced, potentially due to the debilitating/progressive nature of HGG and ongoing caring responsibilities. Future research must explore whether carer interventions can improve carer adjustment, self-efficacy and coping and...
PMC9992082
Supplementary Information
The online version contains supplementary material available at 10.1007/s11060-023-04239-0.
PMC9992082
Keywords
PMC9992082
Introduction
brain cancer, anxiety, IDH, cancer, HGG, depression, oligodendrogliomas, ill, neurological deficits, glioblastoma, cognitive decline, astrocytomas, Brain cancer
BRAIN CANCER, CANCER, HIGH-GRADE GLIOMA, DISEASE, MUTANT, ANAPLASTIC ASTROCYTOMAS, OLIGODENDROGLIOMAS, SECONDARY, GLIOBLASTOMA, ASTROCYTOMAS
Brain cancer in Australia is the sixth leading cause of cancer burden with a 22% five-year relative survival rate [High-grade glioma (HGG) includes grade III anaplastic astrocytomas, oligodendrogliomas and glioblastoma (grade IV). Patients diagnosed with astrocytomas and oligodendrogliomas, IDH mutant, grade 3, may liv...
PMC9992082
Methods
RECRUITMENT
A multistate Phase III RCT was conducted with eight Australian sites, three in Perth, WA and five in Sydney, NSW. CONSORT guidelines guided recruitment, monitoring of response rates, participant withdrawal and reporting.Ethics approval was gained from participating sites (NSW: HREC 16/105; SJOG: 671; SCGH: 2013-172; Cu...
PMC9992082
Participants
HGG
Carers of HGG patients were recruited during patients’ combined chemoradiation treatment. Eligibility criteria included: being a carer of a patient with HGG currently undergoing active treatment (chemotherapy, radiation therapy or combined chemoradiation); within 2 months of initial diagnosis; age 18 years and above; a...
PMC9992082
Recruitment
cancer, HGG
CANCER
Screening for eligibility was carried out by the medical oncologists, radiation oncologist, neuro- surgeons, or neuro-oncology cancer nurse coordinator, at the start of treatment for HGG. As the carer was often present for the patients’ medical appointments, clinicians discussed the trial with both the patients and the...
PMC9992082
Randomisation
ONCOLOGY
Participants were randomised when they had completed the informed consent and baseline questionnaire. Participants were stratified by participating site and the patient’s Eastern Cooperative Oncology Group (ECOG) score (0–1 or ≥ 2) to ensure an even distribution between arms was achieved.Block randomisation to treatmen...
PMC9992082
Intervention
’ disease
The Care-IS intervention was developed by our multidisciplinary team (including a variety of stakeholders and consumer representatives) using the UK Medical Research Council Framework for developing and evaluating complex interventions [The Care-IS complex intervention comprised four components: (1) initial telephone a...
PMC9992082
Usual care
The control arm received ‘
PMC9992082
Measures
depression, Depression, Anxiety, anxiety
Primary outcomes included: carer preparedness measured using the Preparedness for Caregiving Scale [Secondary outcomes included carer anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) [
PMC9992082
Sample size and power calculations
The sample size was calculated based on two co-primary end points: carer preparedness and carer distress at 4 months after randomisation. Using a 5% significance level, two-tailed testing of differences between two independent groups (usual care and intervention), a sample of 64 patients per group (128 total), has 80% ...
PMC9992082
Data analysis
SECONDARY, REGRESSIONS
Descriptive statistics were reported as counts and percentages for categorical variables and means and standard deviations for continuous variables. Logistic regressions were performed to examine drop out at each time point. Caregivers who participated were dummy coded as 1 (retention) and those who dropped out were co...
PMC9992082
Discussion
HGG
The Care-IS intervention was effective in improving carer self-reported preparedness to care at 4 months and subsequent points until 12 months when data collection ceased. This work builds on Boele et al.’s [We found, despite improvements in carer preparedness, for carers who remained in the RCT carer distress was not ...
PMC9992082
Limitations
brain cancer, depression, anxiety
BRAIN CANCER, RECRUITMENT
Our RCT was limited by only including English speaking carers living in Australia. There was a substantial drop-out across both arms in the trial, highlighting the challenges of longitudinal research in this population. Exploration of missing data via sensitivity analyses indicated if participants in the intervention g...
PMC9992082
Conclusion
HGG
DISEASE
This intervention was effective in improving carer self-reported preparedness. However, carer distress was not reduced, potentially due to the debilitating and progressive nature of HGG and their ongoing caring responsibilities as the disease progresses. Future research needs to explore the type and timing of support c...
PMC9992082
Acknowledgements
GILBERT
Thank you to the clinicians who recruited and referred participants; Claire Savage, Emily Hepsworth, Linda Ye, Mary Corker, Michelle McMullen, Sanju Kondola, Tim Humphries, Daphne Tsoi, Elizabeth Hovey, Dari Place, Georgia Ritchie, Joyce Bonello, Cecelia Gzell, Subotheni Thavaneswaran, Suzanne McNella, Tracey Dunlop, K...
PMC9992082
Author contributions
JP, HD, EL
GH, AN, EL, JP, PH conceptualised the project and successfully attracted funding for the study. EM, JC, GH collected the data. RC and KM provided statistical advice and conducted the initial data analysis. GH, EM, RC, HD, EL, AN prepared the manuscript. All authors reviewed the manuscript and provided critical input.
PMC9992082
Funding
Brain cancer, Cancer
CANCER
Open Access funding enabled and organized by CAUL and its Member Institutions. This project was funded by a Cancer Australia Priority-driven Collaborative Cancer Research Scheme project grant (APP1105307). Data analysis was supported by funding from the Medical Research Future Fund for the Brain cancer Rehabilitation, ...
PMC9992082
Declarations
PMC9992082
Competing interests
The authors declare no competing interests.
PMC9992082
References
PMC9992082
Abstract
PMC9835442
Background
VIRUS, INFLUENZA
Persons experiencing homelessness face increased risk of influenza as overcrowding in congregate shelters can facilitate influenza virus spread. Data regarding on‐site influenza testing and antiviral treatment within homeless shelters remain limited.
PMC9835442
Methods
cough, respiratory illness, ARI
INFLUENZA, VIRUS INFECTION, INFLUENZA
We conducted a cluster‐randomized stepped‐wedge trial of point‐of‐care molecular influenza testing coupled with antiviral treatment with baloxavir or oseltamivir in residents of 14 homeless shelters in Seattle, WA, USA. Residents ≥3 months with cough or ≥2 acute respiratory illness (ARI) symptoms and onset <7 days were...
PMC9835442
Results
ARI
VIRUS, INFLUENZA, VIRUS INFECTION, INFLUENZA
During 11/15/2019–4/30/2020 and 11/2/2020–4/30/2021, 1283 ARI encounters from 668 participants were observed. Influenza virus was detected in 51 (4%) specimens using RT‐PCR (A = 14; B = 37); 21 influenza virus infections were detected from 269 (8%) intervention‐eligible encounters by rapid molecular testing and receive...
PMC9835442
Conclusion
INFLUENZA
Our findings suggest feasibility of influenza test‐and‐treat strategies in shelters. Additional studies would help discern an intervention effect during periods of increased influenza activity.
PMC9835442
BACKGROUND
deaths
INFLUENZA
Seasonal influenza is estimated to have caused between 9–41 million illnesses, 140,710,000 hospitalizations and 12,000–52,000 deaths annually between 2010 and 2020 in the United States.Nearly a third of PEH in the United States stay in emergency shelters or transitional housing programs.Rapid point‐of‐care influenza mo...
PMC9835442
METHODS
PMC9835442
Study design overview
SECONDARY, INFLUENZA
We conducted a cluster‐randomized stepped‐wedge trial of a point‐of‐care molecular influenza testing with antiviral treatment intervention in shelters in King County, Washington (WA). The objective of the trial was to evaluate the feasibility and impact of the intervention on the number of secondary influenza cases wit...
PMC9835442
Setting and participants
cough, respiratory illness, ARI
INFLUENZA
This study was conducted initially at nine homeless shelters in King County, WA. Participants were enrolled over a cumulative 12 months, composed of two 6‐month influenza seasons, from 11/15/19 to 4/30/20 in Year 1 and from 11/2/20 to 4/30/21 in Year 2.Study eligibility criteria included being a resident at a participa...
PMC9835442
Randomization and intervention
CORONAVIRUS DISEASE 2019, INFLUENZA
We used a stepped‐wedge cluster‐randomized trial, where randomization occurred at the cluster (shelter) level. The design involved monthly random and sequential crossover of clusters from control periods to intervention periods with influenza testing at kiosks until all clusters implemented the intervention. Nine shelt...
PMC9835442
Study procedures
PMC9835442
Recruitment
Participants were recruited from staffed influenza‐surveillance kiosks at each shelter and screened for eligibility. Participants were recruited 6 days per week. To encourage participation, regular staffed kiosk hours were advertised with flyers and regular announcements at shelters. Telephonic translation services wer...
PMC9835442
Control period
STERILE
Eligible individuals had mid‐turbinate nasal swabs collected (self‐collected by participants from 3/6/2020 onwards) using sterile nylon flocked swabs (Copan Diagnostics) and filled surveys providing self‐reported demographic and clinical data on an electric tablet; survey variables and shelter site data have been previ...
PMC9835442
Intervention period
active malignancy
INFLUENZA A, APPENDIX, LIVER DISEASE, INFLUENZA
Trained kiosk staff conducted on‐site rapid molecular influenza testing (Abbott ID NOW, Abbott Laboratories, Lake Bluff, IL, USA), which detects and distinguishes between influenza A and B, and produces a result in 12 min, using nasal specimens collected from participants. Baloxavir (XOFLUZA, Genentech, San Francisco, ...
PMC9835442