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Evaluation of the effectiveness and transferability of the digital health platform (ProACT) to support home-based multimorbidity self-management in Europe

Scaling European citizen-driven transferable and transformative digital health: a multi-site effectiveness-implementation hybrid trial of the Digital Health Platform ProACT to support older adults managing multiple chronic health conditions (multimorbidity) in Europe

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34134007
Enrollment
2220
Registered
2023-01-20
Start date
2023-01-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multimorbidity consisting of two or more of any of the following: 1. Diabetes 2. Chronic Respiratory Disease (i.e., COPD, Chronic Bronchitis, Emphysema, and Chronic Asthma) 3. Chronic Heart Disease, Coronary Artery Disease, and Cardiovascular Disease (i.e., Hypertension, Atherosclerosis, Angina, and Arrhythmia) 4. Chronic Heart Failure Other

Interventions

This 12-month multi-site trial will adopt a Type 1 Effectiveness-Implementation Hybrid design, which will comprise a pragmatic-Randomised Controlled Trial and process evaluation to assess the effectiv

Sponsors

Trinity College Dublin
Lead Sponsor
Dundalk Institute of Technology
Collaborator
Vrije Universiteit Brussel
Collaborator
Västerbotten County
Collaborator

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: Participants with multimorbidity must: 1. Be aged 65 years old and over 2. Possess sufficient cognitive capacity to provide written informed consent 3. Have at least 2 of the following conditions: diabetes, chronic respiratory disease (e.g. chronic obstructive pulmonary disease (COPD), chronic asthma), chronic heart failure, chronic heart disease (e.g., coronary artery disease, cardiovascular disease (including hypertension, atherosclerosis, angina or arrhythmia)) For care network participants to be included, the person with multimorbidity must provide consent for their participation. Care network participants must: 1. Be aged 18-90 years old and over 2. Be providing support to a consented participant with multimorbidity in trial arm 1 (if they are an informal carer, they must be providing support to a participant with multimorbidity for at least six months; and if they are a formal carer, formal care Quality Assistant, or healthcare professional, they must be formally recognised as such and possess at least two years’ experience of professionally working in a relevant health or primary care setting with people with multimorbidity with the same health conditions as those involved in the current trial) 3. Have access to a tablet, smartphone, or computer with an internet connection 4. Possess the skills to use an internet-based application or website 5. Possess sufficient cognitive capacity to provide written informed consent Partner organisation management and staff must: 1. Be aged 18 or older 2. Be overseeing and/or implementing the delivery of ProACT to their clients with multimorbidity 3. Have access to a tablet, smartphone, or computer with an internet connection 4. Possess the skills to use an internet-based application or website

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Quality of Life measured using the EuroQol EQ-5D-5L questionnaire and Control, Autonomy, Self-realisation and Pleasure Scale (CASP-19) at T1 (baseline) and T7 (at the end of a PwM’s 6-month trial period) 2. Healthcare Utilisation measured using a SEURO trial-designed Healthcare Utilisation questionnaire at the beginning of the trial period, once per month during, and at the end of a PwM’s 6-month trial period (at T1, T2, T3, T4, T5, T6, and T7) Focus is on exploring cost effectiveness using these outcomes.

Secondary

MeasureTime frame
Persons with multimorbidity (PwMs): 1. Type, number, and perceived burden of comorbidities measured, measured using the Comorbidity Index, baseline and 6 months post-baseline 2. Self-care, the belief in one’s ability to self-care, and the self-care of chronic illness, measured using the Self-Care Chronic Illness Inventory, baseline and 6 months post-baseline 3. Medication adherence, measured using the MARS-5, baseline and 6 months post-baseline 4. Health literacy, measured using the HLS-EU-Q16, baseline and 6 months post-baseline 5. Digital health literacy, measured using the eHealth Literacy Scale, baseline and 6 months post-baseline 6. Digital literacy, measured using the MDPQ-16, baseline and 6 months post-baseline 7. Technology acceptance, measured using the UTAUT2, at 6 months 8. The usability of the ProACT technology, measured using the User Burden Scale, at 6 months 9. The utility of and experiences with ProACT, measured using a SEURO-trial-designed ProACT Impact Evaluation questionnaire, at 6 months 10. The health support system of PwMs (e.g., the individuals in PwMs’ care networks and the role they play), measured using a SEURO-trial designed Health Support System questionnaire, baseline and 6 months post-baseline 11. Expectations about ageing (e.g., expectations about physical health, mental health, and cognitive function), measured using the ERA-12, at baseline and 6 months post-baseline 12. Self-management effectiveness (e.g., setting and meeting activity goals and controlling symptoms), measured daily using system data throughout the participants’ trial period (baseline to 6 months post-baseline) and by interview at 6 months 13. Engagement with ProACT, measured daily using system data throughout the participants’ trial period (baseline to 6 months post-baseline) and by interview, at 6 months 14. Experiences with ProACT (e.g., the usability, accessibility, and acceptability of, and engagement, satisfaction, and overall experiences with ProACT) measure

Countries

Belgium, Ireland, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026