Project Aclú - Digital Tool(s) to Promote Physical Activity Within an Irish Residential Care Setting.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Physical Activity Levels
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have an SMI of schizophrenia, bipolar disorder, or psychosis.
- •A service user within one of three HSE mental health residential houses. Capacity to understand the research and consent to the research (Assisted Decision-Making (Capacity) Act 2015).
- •Approved by their clinician.
Exclusion Criteria
- •No SMI diagnosis
- •Acute psychiatric episode at the time of recruitment
- •Service users who are unwell/ distressed
Arms & Interventions
Active Ease Intervention Group
Participants in two intervention houses received access to Active Ease, a co-designed digital physical activity web-based application. Phase One involved 10 weeks of researcher-led support. Following co-design interviews, Phase Two lasted six weeks with clinicians independently facilitating physical activity engagement.
Intervention: Active Ease Digital Physical Activity Intervention (Behavioral)
Control Group (Usual Care)
Participants in the control house continued with their usual residential care without access to Active Ease or any structured physical activity intervention.
Outcomes
Primary Outcomes
Physical Activity Levels
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.
Secondary Outcomes
- Body Mass Index(Change from baseline to approximately 18 months)
- Feasibility and Acceptability of Active Ease(From baseline to approximately 18 months.)
Investigators
Aisling Forde
PhD Candidate
Munster Technological University