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Testing the Recruitment Frequency, Implementation Fidelity, and Feasibility of Outcomes of the Heart Failure Activity Coach Study (HEALTHY): Pilot Randomized Controlled Trial
Linköping University, Department of Health, Medicine and Caring Sciences, Division of Nursing Sciences and Reproductive Health. Linköping University, Faculty of Medicine and Health Sciences.ORCID iD: 0000-0003-1997-7236
Linköping University, Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine. Linköping University, Faculty of Medicine and Health Sciences. Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Gothenburg, Sweden.ORCID iD: 0000-0002-6031-7478
Linköping University, Department of Health, Medicine and Caring Sciences, Division of Nursing Sciences and Reproductive Health. Linköping University, Faculty of Medicine and Health Sciences.ORCID iD: 0000-0002-7493-0353
Linköping University, Department of Health, Medicine and Caring Sciences, Division of Nursing Sciences and Reproductive Health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart Center, Department of Cardiology in Linköping.ORCID iD: 0000-0002-4259-3671
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2025 (English)In: JMIR Formative Research, E-ISSN 2561-326X, Vol. 9, article id e62910Article in journal (Refereed) Published
Abstract [en]

Background: Heart failure (HF) is a common and deadly disease, precipitated by physical inactivity and sedentary behavior. Although the 1-year survival rate after the first diagnosis is high, physical inactivity and sedentary behavior are associated with increased mortality and negatively impact the health-related quality of life (HR-QoL).

Objective: We tested the recruitment frequency, implementation fidelity, and feasibility of outcomes of the Activity Coach app that was developed using an existing mobile health (mHealth) tool, Optilogg, to support older adults with HF to be more physically active and less sedentary.

Methods: In this pilot clinical randomized controlled trial (RCT), patients with HF who were already using Optilogg to enhance self-care behavior were recruited from 5 primary care health centers in Sweden. Participants were randomized to either have their mHealth tool updated with the Activity Coach app (intervention group) or a sham version (control group). The intervention duration was 12 weeks, and in weeks 1 and 12, the participants wore an accelerometer daily to objectively measure their physical activity. The HR-QoL was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), and subjective goal attainment was assessed using goal attainment scaling. Baseline data were collected from the participants’electronic health records (EHRs).

Results: We found 67 eligible people using the mHealth tool, of which 30 (45%) initially agreed to participate, with 20 (30%) successfully enrolled and randomized to the control and intervention groups in a ratio of 1:1. The participants’ daily adherence to registering physical activity in the Activity Coach app was 69% (range 24%-97%), and their weekly adherence was 88% (range 58%-100%). The mean goal attainment score was –1.0 (SD 1.1) for the control group versus 0.6 (SD 0.6) for the intervention group (P=.001). The mean change in the overall HR-QoL summary score was –9 (SD 10) for the control group versus 3 (SD 13) in the intervention group (P=.027). There was a significant difference in the physical limitation scores between the control (mean 45, SD 27) and intervention (mean 71, SD 20) groups (P=.04). The average length of sedentary bouts increased by 27 minutes to 458 (SD 84) in the control group minutes and decreased by 0.70 minutes to 391 (SD 117) in the intervention group (P=.22). There was a nonsignificant increase in the mean light physical activity (LPA): 146 (SD 46) versus 207 (SD 80) minutes in the control and intervention groups, respectively (P=.07).

Conclusions: The recruitment rate was lower than anticipated. An active recruitment process is advised if a future efficacy study is to be conducted. Adherence to the Activity Coach app was high, and it may be able to support older adults with HF in being physically active.

Trial Registration: ClinicalTrials.gov NCT05235763; https://clinicaltrials.gov/study/NCT05235763

Place, publisher, year, edition, pages
JMIR Publications, 2025. Vol. 9, article id e62910
Keywords [en]
heart failure; disease management; physical activity; sedentary; older adults; aging; mobile health; mHealth; feasibility; quality of life; digital health; smartphone
National Category
Public Health, Global Health and Social Medicine
Identifiers
URN: urn:nbn:se:liu:diva-210946DOI: 10.2196/62910ISI: 001394213500002PubMedID: 39778202Scopus ID: 2-s2.0-85214532059OAI: oai:DiVA.org:liu-210946DiVA, id: diva2:1927534
Note

Funding Agencies|Multimedia Appendix CONSORT-eHEALTH

Available from: 2025-01-15 Created: 2025-01-15 Last updated: 2025-01-22
In thesis
1. Supporting physical activity in people with heart failure: Novel Tools for Intervention and Assessment
Open this publication in new window or tab >>Supporting physical activity in people with heart failure: Novel Tools for Intervention and Assessment
2024 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background

Heart failure is a common disease affecting well over 20 million people worldwide. In addition to pharmacological therapy, self-care is efficacious in improving prognosis and generating symptom relief in this population and one important part of self-care behaviour is physical activity. Physical inactivity and sedentary behaviour negatively affect prognosis for the heart failure population but achieving sustained behaviour change relating to physical activity is challenging. There is research published on how to positively influence behaviours relating to physical activity and one means by which this can be achieved is using mobile health applications. One such mobile health tool, which is designed to enhance self-care behaviour is called Optilogg and it constitutes an appropriate platform on which to develop a novel tool to address sedentary behaviour and physical inactivity.

Aim

The aim of this thesis was to develop and evaluate tools for assessing and supporting physical activity in patients with heart failure.

Methods

This thesis describes the development and testing of two tools, through four scientific studies, employing both quantitative and qualitative methods of data collection and analyses. Study I (n = 106) was a cross-sectional study to test a single item self-report screening tool for identifying physically inactive people with heart failure. Study II (n = 10) describes the mixed-method evaluation of the intervention tool called the Activity Coach, along with the development process. Studies III and IV served to evaluate the Activity Coach in terms of study design, potential outcomes and user experiences. Study III (n = 20) was a pilot randomized controlled clinical trial and Study IV (n = 10) a qualitative study using thematic analysis.

Results

The screening tool studied (Study I) had a high specificity (92%), but low sensitivity (30%) in correctly identifying physically inactive people and correlated significantly (ρ = 0.24, p = 0.016) with an objective measure of physical activity. The whole development process of the Activity Coach took 76 months, with the process of defining and implementing it taking 21 months. Key development elements included co-design, defining factor-action pairs, intervention theory, and mixed-method evaluations. The mixed-methods analyses (Study II) showed an acceptable system adherence of 61% and that it could increase motivation to be physically active, but that user selection likely matters, and too physically active people should not be targeted. The pilot randomized controlled clinical trial (Study III) showed that recruiting people for this type of study, while also screening for physical inactivity was challenging with a recruitment rate of 22%. There were significant effects on subjective goal-attainment and health-related quality of life, and a trend towards reduced sedentary behaviour. Following improvements made prior to Study III, the system adherence increased to 69%. The qualitative analysis (Study IV) showed that the Activity Coach was user-friendly, increased motivation to be physically active and that users experienced positive effects on physical health and emotional well-being.

Conclusions

A single-item self-report screening tool may be used to identify those in extra need of intervention. A pilot trial showed challenges in recruiting participants. It also showed high system adherence and potential benefits in subjective goal-attainment and health-related quality of life. Qualitative analyses of user experience highlighted perceptions of user-friendliness and a sense of enhanced well-being. Further validation and updates are recommended before a full efficacy trial is undertaken.

Abstract [sv]

Bakgrund

Hjärtsvikt är en mycket vanlig sjukdom med över 20 miljoner människor drabbade världen över. Förutom farmakologisk behandling är egenvård mycket effektivt i denna population och en viktig del av egenvårdsbeteendet är fysisk aktivitet. Fysisk inaktivitet och stillasittande beteende påverkar prognosen negativt för personer med hjärtsvikt, men att uppnå varaktig beteendeförändring rörande fysisk aktivitet är utmanande. Det finns dock mycket forskning publicerad om hur man kan påverka beteenden relaterade till fysisk aktivitet positivt, och ett sätt att uppnå detta är genom användning av mobilhälsoappar. Ett dylikt verktyg som är utformat för att förbättra egenvårdsbeteendet kallas Optilogg och utgör en lämplig plattform för att utveckla ett nytt verktyg för att hantera stillasittande beteende och fysisk inaktivitet.

Syfte

Syftet med denna avhandling var att utveckla och utvärdera verktyg för att bedöma och stödja fysisk aktivitet hos patienter med hjärtsvikt.

Metoder

Denna avhandling beskriver utvecklingen och testningen av två verktyg genom fyra vetenskapliga studier, användandes både kvantitativa och kvalitativa metoder för datainsamling och analys. Studie I (n = 106) var en tvärsnittsstudie för att testa ett självrapporteringsverktyg för att identifiera fysiskt inaktiva personer med hjärtsvikt. Studie II (n = 10) beskriver utvärderingen av utvecklingen av interventionsverktyget kallat Aktivitetscoachen, tillsammans med själva utvecklingsprocessen. Studie III (n = 20) var en pilot randomiserad kontrollerad klinisk studie och Studie IV (n = 10) en kvalitativ studie med tematisk analys, och dessa två studier tjänade till att utvärdera Aktivitetscoachen avseende studiedesign, potentiella utfall och användarupplevelser.

Resultat

Det undersökta screeningsverktyget (Studie I) hade en hög specificitet (92%) men låg sensitivitet (30%) sett till att korrekt identifiera fysiskt inaktiva personer, och korrelerade signifikant (ρ = 0,24, p = 0,016) med ett objektivt mått på fysisk aktivitet. Hela utvecklingsprocessen av Aktivitetscoachen tog 76 månader, och att definiera och implementera den tog 21 månader. Kvantitativa och kvalitativa analyser efter utvecklingen (Studie II) visade på en acceptabel systemföljsamhet på 61% och att Aktivitetscoachen kunde öka motivationen att vara fysiskt aktiv, men att urvalet av användare sannolikt är viktigt och att fysiskt aktiva personer inte bör utrustas med verktyget. Den pilot randomiserade kontrollerade kliniska studien (Studie III) visade att det var utmanande att rekrytera personer till denna typ av studie samtidigt som man screenade för fysisk inaktivitet, och uppnådde en rekryteringsgrad på 22%. Det fanns signifikanta effekter på subjektiv måluppfyllelse och hälsorelaterad livskvalitet, samt en trend mot minskat stillasittande. Förbättringar av Aktivitetscoachen inför Studie III medförde ökad systemföljsamhet till 69%. Den kvalitativa analysen (Studie IV) visade att Aktivitetscoachen var användarvänlig, ökade motivationen att vara fysiskt aktiv och att användarna upplevde positiva effekter på fysisk hälsa och känslomässigt välbefinnande.

Slutsatser

Ett självrapporteringsverktyg baserat på en screening-fråga, kan användas för att identifiera de som är i extra behov av stöd kopplat till sin fysiska aktivitetsnivå. Mobilhälsoappen Aktivitetscoachen utvecklades baserat på vetenskapliga metoder för att främja fysisk aktivitet. Viktiga utvecklingselement inkluderade samskapande, definiering av faktor-handlingspar, interventionsteori och utvärderingar med kvantitativa och kvalitativa metoder. En pilotstudie visade utmaningar i att rekrytera deltagare. Den visade också hög systemföljsamhet och potentiella fördelar i subjektiv måluppfyllelse och hälsorelaterad livskvalitet. Kvalitativ analys av användarupplevelser avslöjade hög upplevd användarvänlighet och positiva upplevelser med avseende på välbefinnande. Vidare validering och uppdateringar rekommenderas innan en fullskalig studie med syfte att bekräfta effekt genomförs.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2024. p. 76
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1930
Keywords
mHealth, Behaviour change, Physical activity, Heart failure, Mixed-methods, Co-design, Pilot-RCT, Sedentary behaviour, Screening, Physical inactivity
National Category
Physiotherapy
Identifiers
urn:nbn:se:liu:diva-208113 (URN)10.3384/9789180757508 (DOI)9789180757492 (ISBN)9789180757508 (ISBN)
Public defence
2024-11-07, K3, Kåkenhus, Campus Norrköping, Norrköping, 13:00 (English)
Opponent
Supervisors
Available from: 2024-10-04 Created: 2024-10-04 Last updated: 2025-02-11Bibliographically approved

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Blomqvist, AndreasBäck, MariaKlompstra, LeonieStrömberg, AnnaJaarsma, Tiny

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