Development and usability testing of HEARTPA♀N: protocol for a mixed methods strategy to develop an integrated smartphone and web-based intervention for women with cardiac pain
France Légare,
Colleen Norris,
Monica Parry,
Hance Clarke,
Michael McGillion,
Ann Kristin Bjørnnes,
Jennifer Stinson,
Abida Dhukai,
Joseph A Cafazzo,
Lynn Cooper,
Paula Harvey,
Joel Katz,
Chitra Lalloo,
Marit Leegaard,
Mike Lovas,
Judith McFetridge-Durdle,
Laura Parente,
Rose Patterson,
Louise Pilote,
Leah Pink,
Jennifer Price,
Akib Uddin,
J Charles Victor,
Judy Watt-Watson,
Carol Auld,
Christine Faubert,
Deborah Park,
Marianne Park,
Beatrice Rickard,
Vincenza Spiteri DeBonis
Affiliations
France Légare
9 Faculty of Medicine, Universite Laval, Quebec, Quebec, Canada
Colleen Norris
Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada
Monica Parry
Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada
Hance Clarke
1 Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada
Michael McGillion
Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
Ann Kristin Bjørnnes
Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway
Jennifer Stinson
Child Health Evaluative Sciences, SickKids Research Institute, Toronto, Ontario, Canada
Abida Dhukai
University of Toronto Lawrence S Bloomberg Faculty of Nursing, Toronto, Ontario, Canada
Joseph A Cafazzo
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada
Lynn Cooper
Canadian Injured Workers Alliance, Thunder Bay, Ontario, Canada
Paula Harvey
3University of Toronto, Cardiology, Toronto, Canada
Joel Katz
Department of Psychology, York University, Toronto, Ontario, Canada
Chitra Lalloo
Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada
Marit Leegaard
Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway
Mike Lovas
Cancer Digital Intelligence, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada
Judith McFetridge-Durdle
College of Nursing, Florida State University, Tallahassee, Florida, USA
Laura Parente
Healthcare Human Factors, University Health Network, Toronto, Ontario, Canada
Rose Patterson
Anishnawbe Health, Toronto, Ontario, Canada
Louise Pilote
18 Department of Medicine, McGill University, Montreal, Quebec, Canada
Leah Pink
Wasser Pain Management Centre, Sinai Health System, Toronto, Ontario, Canada
Jennifer Price
Women`s College Hospital, Toronto, Ontario, Canada
Akib Uddin
Healthcare Human Factors, University Health Network, Toronto, Ontario, Canada
J Charles Victor
University of Toronto, Toronto, Ontario, Canada
Judy Watt-Watson
Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada
Introduction More women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men. The overall goal of this programme of research is to develop an integrated smartphone and web-based intervention (HEARTPA♀N) to help women recognise and self-manage cardiac pain.Methods and analysis This protocol outlines the mixed methods strategy used for the development of the HEARTPA♀N content/core feature set (phase 2A), usability testing (phase 2B) and evaluation with a pilot randomised controlled trial (RCT) (phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop HEARTPA♀N. The phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (phase 4, future work). Patient partners have been actively involved in setting the HEARTPA♀N research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life (HRQoL). As such, the guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3). Quantitative data (eg, demographic and clinical information) will be summarised using descriptive statistics (phases 2AB and 3) and a content analysis will be used to identify themes (phase 2AB). A process evaluation will be used to assess the feasibility of the implementation of the intervention and a preliminary efficacy evaluation will be undertaken focusing on the outcomes of pain and HRQoL (phase 3).Ethics and dissemination Ethics approval was obtained from the University of Toronto (36415; 26 November 2018). We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars.Trial registration number NCT03800082.
