Munster Technological University
Cork, T12P928, Ireland
NCT Number: NCT07746609
The goal of this clinical trial is to collaboratively develop and evaluate Active Ease, a co-designed, web-based digital physical activity application, to promote and maintain physical activity levels among individuals with severe mental illness in an Irish mental health residential care setting.
The main questions it aims to answer are:
* What are the barriers and facilitators individuals with severe mental illness face when participating in physical activity within an Irish mental health residential setting? * What is the potential role of digital technologies in promoting and maintaining physical activity engagement for individuals with severe mental illness? * Can a co-designed digital physical activity intervention, developed with HSE clinicians and service users, effectively promote and maintain physical activity levels among individuals with severe mental illness in an Irish mental health residential setting?
Researchers will compare two intervention houses receiving Active Ease to one control house receiving usual care.
Participants will:
* Engage with Active Ease across two consecutive intervention phases * Wear a GENEActiv accelerometer for seven consecutive days at each data collection timepoint * Have their body mass index recorded * Participate in semi-structured interviews about their experience of Active Ease * Complete a follow-up assessment at +12 weeks post-Phase Two
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Cork, T12P928, Ireland
Active Ease is a co-designed digital-physical activity web-based application developed for individuals with severe mental illness (SMI) in Irish mental health residential settings. The platform was adapted from the Move More Toolkit (Anthony et al., 2024), originally developed at Loughborough University, and informed by Public and Patient Involvement (PPI) feedback from service users and clinicians. Active Ease includes an educational homepage and a range of physical activities with guided visual demonstrations, including videos and images.
The intervention was underpinned by the Capability, Opportunity, Motivation - Behaviour (COM-B) model and evaluated using the RE-AIM framework. A clustered randomised controlled trial design was employed across three Irish mental health residential houses. Two houses were randomly assigned as intervention houses and one as a control.
The intervention was delivered across two consecutive phases. Phase One involved a 10-week researcher-led pilot in which the researcher served as a digital navigator, supporting service users in engaging with Active Ease individually or in groups. Following co-design interviews with service users and clinicians, iterative refinements were made to Active Ease for Phase Two. Phase Two lasted six weeks and shifted its focus to empowering clinicians to independently facilitate service users' engagement in physical activity, with the researcher adopting a facilitative role. Environmental adaptations introduced in Phase Two included screen mirroring Active Ease to communal televisions and placement of visual aids and a guidebook within the residential settings.
Follow-up data were collected at +12 weeks post-Phase Two to evaluate the maintenance of Active Ease engagement and early indicators of sustainability. Qualitative data were analysed using reflexive thematic analysis informed by Braun and Clarke (2019), with findings mapped onto the RE-AIM framework.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active Ease is a co-designed digital-physical activity web-based application developed for individuals with severe mental illness in Irish mental health residential settings. The platform was adapted from the Move More Toolkit and informed by feedback from Public and Patient Involvement service users and clinicians. Active Ease includes an educational homepage on the benefits of physical activity and a range of physical activities with guided visual demonstrations, including videos and images. The intervention was delivered across two consecutive phases: Phase One lasted 10 weeks with the researcher acting as a digital navigator and physical activity facilitator; Phase Two lasted six weeks with the researcher supporting clinicians to independently facilitate physical activity engagement among service users. Environmental adaptations in Phase Two included screen mirroring Active Ease to communal televisions and placement of visual aids and a guidebook within the residential settings. Th
Other names: Active Ease
Time frame: Change from baseline to approximately 18 months
Physical activity levels were assessed objectively using a wrist-worn GENEActiv accelerometer worn for seven consecutive days at each time point. Data were processed using ActivInsights software and analysed in SPSS. Outcome variables included steps, light physical activity, moderate physical activity, vigorous physical activity, steps and sedentary behaviour.
Time frame: Change from baseline to approximately 18 months
BMI was calculated from weight and height measurements (kg/m²). Weight was measured using a calibrated electronic scale (Seca Model 875), and height was obtained by a clinical psychologist.
Time frame: From baseline to approximately 18 months.
Semi-structured interviews were conducted with service users and clinicians at baseline, post-Phase One, and +12 weeks follow-up. Baseline interviews were conducted as part of a cross-sectional study reported separately. Post-Phase One interviews informed iterative refinements to Active Ease for Phase Two through a co-design process. Interviews were analysed using reflexive thematic analysis informed by Braun and Clarke (2019) and mapped onto the RE-AIM framework. Post-Phase One interviews focused on Reach, Effectiveness, Adoption and Implementation dimensions. Follow-up interviews focused on the Maintenance dimension.
Munster Technological University
Other
Project Aclú - Digital Tool(s) to Promote Physical Activity Within an Irish Residential Care Setting.
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