Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse
Abstract Background Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regu...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-09-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06681-3 |
| _version_ | 1811273598735745024 |
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| author | Lucy Dwyer Carol Bugge Suzanne Hagen Kirsteen Goodman Wael Agur Melanie Dembinsky Margaret Graham Karen Guerrero Christine Hemming Aethele Khunda Doreen McClurg Lynn Melone Ranee Thakar Rohna Kearney The TOPSY Team |
| author_facet | Lucy Dwyer Carol Bugge Suzanne Hagen Kirsteen Goodman Wael Agur Melanie Dembinsky Margaret Graham Karen Guerrero Christine Hemming Aethele Khunda Doreen McClurg Lynn Melone Ranee Thakar Rohna Kearney The TOPSY Team |
| author_sort | Lucy Dwyer |
| collection | DOAJ |
| description | Abstract Background Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention. Methods The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura’s social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition. Results The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team. Conclusions The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management. Trial registration ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017 |
| first_indexed | 2024-04-12T23:02:09Z |
| format | Article |
| id | doaj.art-2bf0bbf48dd74635a94a48d7f387a97f |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T23:02:09Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-2bf0bbf48dd74635a94a48d7f387a97f2022-12-22T03:13:00ZengBMCTrials1745-62152022-09-0123111010.1186/s13063-022-06681-3Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapseLucy Dwyer0Carol Bugge1Suzanne Hagen2Kirsteen Goodman3Wael Agur4Melanie Dembinsky5Margaret GrahamKaren Guerrero6Christine Hemming7Aethele Khunda8Doreen McClurg9Lynn Melone10Ranee Thakar11Rohna Kearney12The TOPSY TeamThe Warrell Unit, St. Mary’s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science CentreHealth Sciences & Sport, University of StirlingNursing, Midwifery & Allied Health Professions Research Unit, Glasgow Caledonian UniversityNursing, Midwifery & Allied Health Professions Research Unit, Glasgow Caledonian UniversityNHS Ayrshire & Arran, Crosshouse HospitalHealth Sciences & Sport, University of StirlingDepartment of Urogynaecology, NHS Greater Glasgow & ClydeAberdeen Maternity Hospital & Aberdeen Royal Infirmary, Grampian University Hospitals NHS TrustSouth Tees Hospitals NHS Foundation Trust, James Cook University HospitalNursing, Midwifery & Allied Health Professions Research Unit, Glasgow Caledonian UniversityNursing, Midwifery & Allied Health Professions Research Unit, Glasgow Caledonian UniversityCroydon Health Services NHS Trust, Croydon University HospitalThe Warrell Unit, St. Mary’s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science CentreAbstract Background Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention. Methods The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura’s social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition. Results The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team. Conclusions The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management. Trial registration ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017https://doi.org/10.1186/s13063-022-06681-3ProlapsePessarySelf-managementSelf-efficacyRandomised controlled trial (RCT)Intervention development |
| spellingShingle | Lucy Dwyer Carol Bugge Suzanne Hagen Kirsteen Goodman Wael Agur Melanie Dembinsky Margaret Graham Karen Guerrero Christine Hemming Aethele Khunda Doreen McClurg Lynn Melone Ranee Thakar Rohna Kearney The TOPSY Team Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse Trials Prolapse Pessary Self-management Self-efficacy Randomised controlled trial (RCT) Intervention development |
| title | Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse |
| title_full | Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse |
| title_fullStr | Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse |
| title_full_unstemmed | Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse |
| title_short | Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse |
| title_sort | theoretical and practical development of the topsy self management intervention for women who use a vaginal pessary for pelvic organ prolapse |
| topic | Prolapse Pessary Self-management Self-efficacy Randomised controlled trial (RCT) Intervention development |
| url | https://doi.org/10.1186/s13063-022-06681-3 |
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