Abstract
Investigating the mechanisms of behavior change interventions provides a more fulsome understanding of how and why interventions work (or don’t work). We assessed mechanisms of two interventions (mailouts alone, and mailouts plus telephone support, informed by the Health Action Process Approach (HAPA) and Habit Theory), designed to increase medication adherence after myocardial infarction. We conducted a process evaluation alongside a pragmatic trial. Medication adherence was assessed via self-report at 12-months in the trial, and participants in all trial groups were invited to contemporaneously complete an additional questionnaire assessing targeted mechanisms (HAPA constructs and automaticity). We used multiple regression-based mediation models to investigate indirect effects. Of 589 respondents, 497 were analyzed (92 excluded due to missing data). Mailouts plus telephone support had statistically significant but small effects on intention, social support, action planning, coping planning, and automaticity. There were no indirect effects of interventions on medication adherence via these constructs. Therefore, while this intervention led to changes in proposed mechanisms, these changes were not great enough to lead to behavior change. Refinements (and subsequent evaluation) of the interventions are warranted, and our findings indicate that this could involve offering more intensive support to form plans and identify cues for taking medications, in addition to providing physical supports to encourage self-monitoring, feedback, and habit formation.
Trial registration: ClinicalTrials.gov: NCT02382731.
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Availability of data and material
De-identified data from this study are not available in a public archive. De-identified data from this study will be made available (as allowable according to institutional ethics board standards) by emailing the corresponding author. Some of the materials used to conduct the study are available as part of a previous open-access publication: https://doi.org/10.2196/humanfactors.6502.
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Analytic code used to conduct the analyses presented in this study are not available in a public archive. They may be available by emailing the corresponding author.
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Acknowledgements
The authors would like to thank the study participants for giving up their valuable time to take part in this research. Thanks also to Dr. Madhu Natarajan for reviewing a previous draft of the manuscript.
Funding
This study was funded in part by a grant from the Province of Ontario. The opinions, results and conclusions in this paper are those of the authors and are independent from the Province. The funder was not involved in the design of the study or the writing of this manuscript. N.M.I. is supported by a Canada Research Chair (tier 2) in Implementation of Evidence Based Practice, as well as a Clinician Scholar Award from the University of Toronto Department of Family and Community Medicine. H.O.W. is supported by a Research Scholar Junior 1 award from the Fonds de recherché du Québec – Santé. J.M.G. is supported by a Tier 1 Canada Research Chair in Health Knowledge Transfer and Uptake and a CIHR Foundation grant for related work.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Ethical approval for the trial was provided by the nine cardiac centers involved (Hamilton General Hospital, Kingston General Hospital, London Health Sciences Centre, Peterborough Regional Health Care, St Catharines General Hospital, Sunnybrook Health Sciences Centre, Trillium Health Partners, University Health Network, and William Osler Health Centre). Ethics approval for the analyses reported here was granted by the Women’s College Hospital Research Ethics Board (#2017-0135-E), and the Ottawa Health Science Network Research Ethics Board (#20170832-01H).
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McCleary, N., Ivers, N.M., Schwalm, JD. et al. Impacts of two behavior change interventions on determinants of medication adherence: process evaluation applying the health action process approach and habit theory alongside a randomized controlled trial. J Behav Med 45, 659–673 (2022). https://doi.org/10.1007/s10865-022-00327-0
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DOI: https://doi.org/10.1007/s10865-022-00327-0