DiabetesFlex™ – the effect of PRO-based telehealth and user involvement in care management of patients with type 1 diabetes: Trial protocol for a non-inferiority randomised controlled study DiabetesFlex™
Main Article Content
Annesofie Lunde Jensen
http://orcid.org/0000-0003-2025-6663
Kirsten Lomborg, KL
http://orcid.org/0000-0002-5809-3508
Niels Henrik Hjollund, NHH
http://orcid.org/0000-0003-2025-6663
Kirsten Lomborg, KL
http://orcid.org/0000-0002-5809-3508
Niels Henrik Hjollund, NHH
http://orcid.org/0000-0002-6697-6597
Liv Valen Schougaard, LS
http://orcid.org/0000-0003-2928-2569
Laila Beck Olesen, LBO
http://orcid.org/0000-0002-8624-5679
Tinne Laurberg, TL
http://orcid.org/0000-0002-7555-2665
Troels Kraup Hansen, TKH
http://orcid.org/0000-0002-0708-2868
Abstract
Background: This trial focuses on management of care for patients with type 1 diabetes, patient involvement and use of patient-reported outcome (PRO)-based telehealth. Despite available knowledge on the use of different kinds of PRO measures in diabetes care, studies that use PRO in remote monitoring in diabetes management are scarce.
Objective: The aim of this pragmatic randomised controlled non-inferiority study is to investigate the effect using a PRO-based telehealth intervention, DiabetesFlex, on health outcome, user involvement and healthcare utilisation in patients with type 1 diabetes.
Methods: This trial plans to recruit 400 patients with type 1 diabetes treated at an outpatient clinic at XXXX University Hospital. The participants will fill in an electronic questionnaire covering health outcome and patient involvement at baseline and at end of the study period (15 month). Data on HbA1c, blood pressure, urine albumin/creatinine ratio and resource (number of contacts and consultations) will be drawn from the patients’ medical records at baseline and at 4, 8, 12 and 15 months. Patients will be randomised to either DiabetesFlex™ (a patient-initiated and PRO-driven protocol) or standard care. The patient perspective on the use of DiabetesFlex™ will be explored in a qualitative study.
Conclusion: This study will seek to outline significant knowledge on what matters to the people with diabetes in relation to involvement in care planning. As well as factors related to patients’ experiences concerning the use of PRO measures. This is important components in diabetes care management.
Trial registration: ClinicalTrials.gov. NCT03202732
Keywords:
Type 1 diabetes, Patient-reported outcome Measures, Patient involvement, Diabetes management, Outpatient follow-up, Randomised controlled trial, Interpretive Description
Article Details
How to Cite
JENSEN, Annesofie Lunde et al.
DiabetesFlex™ – the effect of PRO-based telehealth and user involvement in care management of patients with type 1 diabetes: Trial protocol for a non-inferiority randomised controlled study.
Medical Research Archives, [S.l.], v. 8, n. 7, july 2020.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/2145>. Date accessed: 24 nov. 2024.
doi: https://doi.org/10.18103/mra.v8i7.2145.
Section
Review Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
American Diabetes A. Standards of Medical Care in Diabetes—2019. Diabetes care. 2019;41(1):1-193.
2. Tamhane S, Rodriguez-Gutierrez R, Hargraves I, Montori VM. Shared Decision-Making in Diabetes Care. Curr Diab Rep. 2015;15(12):112. [http://dx.doi.org/10.1007/s11892-015-0688-0]
3. Society TDE. NBV: Type 1 Diabetes Mellitus: The Danish Endocrine Society 2016 [Available from: http://www.endocrinology.dk/index.php/1-diabetes-mellitus/3-type-1-diabetes-mellitus.
4. Federatin ID. IDF DIABETES ATLAS 2017 [1]. Available from: https://www.diabetesatlas.org/.
5. Taneja A, Su'a B, Hill AG. Efficacy of patient-initiated follow-up clinics in secondary care: a systematic review. Internal medicine journal. 2014;44(12a):1156-60. [http://dx.doi.org/10.1111/imj.12533]
6. Whear R, Abdul-Rahman A-K, Boddy K, Thompson-Coon J, Perry M, Stein K. The clinical effectiveness of patient initiated clinics for patients with chronic or recurrent conditions managed in secondary care: a systematic review. PloS one. 2013;8(10):e74774. [http://dx.doi.org/10.1371/journal.pone.0074774]
7. Administration FAD. Patient-Reported Outcome Measures Use in Medical Product Development to Support Labeling Claims Services USDoHaH; 2009.
8. Hjollund NHI. Fifteen Years' Use of Patient-Reported Outcome Measures at the Group and Patient Levels: Trend Analysis. J Med Internet Res. 2019;21(9):e15856. [http://dx.doi.org/10.2196/15856]
9. Schougaard LMV, Larsen LP, Jessen A, Sidenius P, Dorflinger L, de Thurah A, et al. AmbuFlex: tele-patient-reported outcomes (telePRO) as the basis for follow-up in chronic and malignant diseases. Quality of Life Research. 2016;25(3):525-34. [http://dx.doi.org/10.1007/s11136-015-1207-0]
10. Mejdahl CT, Schougaard LMV, Hjollund NH, Riiskjær E, Thorne S, Lomborg K. PRO-based follow-up as a means of self-management support – an interpretive description of the patient perspective. Journal of Patient-Reported Outcomes. 2018;2(1):1-9. [http://dx.doi.org/10.1186/s41687-018-0067-0]
11. Thurah A, Stengaard-Pedersen K, Axelsen M, Fredberg U, Schougaard LMV, Hjollund NHI, et al. Tele-health Follow-up Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of the Non-inferiority Randomised Controlled Trail (the TeRA study). Arthritis care & research. 2018;0(0). [http://dx.doi.org/10.1002/acr.23280 [doi]]
12. Scholle SH, Morton S, Rodriguez K, Hahn E, Bardach D. Implementation of the PROMIS-29 in Routine Care for People With Diabetes Challenges and Opportunities. The Journal of ambulatory care management. 2018;41(4):274-87. [http://dx.doi.org/10.1097/JAC.0000000000000248]
13. Mejdahl CT, Schougaard LMV, Hjollund NH, Riiskjær E, Lomborg K. Exploring organisational mechanisms in PRO-based follow-up in routine outpatient care - an interpretive description of the clinician perspective. BMC health services research. 2018;18(1):1-12. [http://dx.doi.org/10.1186/s12913-018-3352-y]
14. Speight J, Reaney MD, Barnard KD. Not all roads lead to Rome-a review of quality of life measurement in adults with diabetes. Diabetic medicine : a journal of the British Diabetic Association. 2009;26(4):315-27. [http://dx.doi.org/10.1111/j.1464-5491.2009.02682.x]
15. Shrivastava SR, Shrivastava PS, Ramasamy J. Role of self-care in management of diabetes mellitus. Journal of diabetes and metabolic disorders. 2013;12(1):14. [http://dx.doi.org/10.1186/2251-6581-12-14]
16. Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J. Self-management approaches for people with chronic conditions: a review. Patient education and counseling. 2002;48(2):177-87. [http://dx.doi.org/10.1016/S0738-3991(02)00032-0]
17. Chatterjee S, Davies MJ, Heller S, Speight J, Snoek FJ, Khunti K. Diabetes structured self-management education programmes: a narrative review and current innovations. Lancet Diabetes Endocrinol. 2018;6(2):130-42. [http://dx.doi.org/10.1016/S2213-8587(17)30239-5]
18. Calvert M, Kyte D, Price G, Valderas JM, Hjollund NH. Maximising the impact of patient reported outcome assessment for patients and society. BMJ (Clinical research ed). 2019;364:k5267. [http://dx.doi.org/10.1136/bmj.k5267]
19. Organization WH. Telemedicin: opportunities and developments in Member States: report on the second global survey on eHealth. WHO; 2010.
20. Schougaard LM, Mejdahl CT, Petersen KH, Jessen A, de Thurah A, Sidenius P, et al. Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study. BMC health services research. 2017;17(1):83-017-2015-8. [http://dx.doi.org/10.1186/s12913-017-2015-8 [doi]]
21. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ (Clinical research ed). 2008;337(7680):1223-6. [http://dx.doi.org/10.1136/bmj.a2390]
22. Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT, et al. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. Jama. 2018;319(5):483-94. [http://dx.doi.org/10.1001/jama.2017.21903 [doi]]
23. Tang TS, Yusuf FLA, Polonsky WH, Fisher L. Assessing quality of life in diabetes: II - Deconstructing measures into a simple framework. Diabetes Res Clin Pract. 2017;126:286-302. [http://dx.doi.org/10.1016/j.diabres.2016.10.007]
24. Drennan J. Cognitive interviewing: verbal data in the design and pretesting of questionnaires. Journal of advanced nursing. 2003;42(1):57-63. [http://dx.doi.org/2579 [pii]]
25. Nielsen BK, Lomborg K, Munch-Hansen T, Riiskjær E. Indikatormål for patientinddragelse - teoretiske og metodiske overvejelser [Measures for patient involvement – Theoretical and methodological considerations]. 2015. Contract No.: Report.
26. Maindal HT, Sokolowski I, Vedsted P. Translation, adaptation and validation of the American short form Patient Activation Measure (PAM13) in a Danish version. BMC public health. 2009;9(1):209-. [http://dx.doi.org/10.1186/1471-2458-9-209]
27. Maindal HT, Kayser L, Norgaard O, Bo A, Elsworth GR, Osborne RH. Cultural adaptation and validation of the Health Literacy Questionnaire (HLQ): robust nine-dimension Danish language confirmatory factor model. SpringerPlus. 2016;5(1):1232-016-2887-9. eCollection 016. [http://dx.doi.org/10.1186/s40064-016-2887-9 [doi]]
28. Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelova A, Thomsen HF, et al. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Current medical research and opinion. 2009;25(12):2887-94. [http://dx.doi.org/10.1185/03007990903354674 [doi]]
29. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics. 2009;42(2):377-81. [http://dx.doi.org/10.1016/j.jbi.2008.08.010]
30. Thorne S. Interpretive Description. Qualitative research for applied practice 2, editor. New York and London Routledge 2016 2016.
31. Reaney M, Black P, Gwaltney C. A systematic method for selecting patient-reported outcome measures in diabetes research. Diabetes spectrum : a publication of the American Diabetes Association. 2014;27(4):229-32. [http://dx.doi.org/10.2337/diaspect.27.4.229]
32. World Medical A. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191-4. [http://dx.doi.org/10.1001/jama.2013.281053]
2. Tamhane S, Rodriguez-Gutierrez R, Hargraves I, Montori VM. Shared Decision-Making in Diabetes Care. Curr Diab Rep. 2015;15(12):112. [http://dx.doi.org/10.1007/s11892-015-0688-0]
3. Society TDE. NBV: Type 1 Diabetes Mellitus: The Danish Endocrine Society 2016 [Available from: http://www.endocrinology.dk/index.php/1-diabetes-mellitus/3-type-1-diabetes-mellitus.
4. Federatin ID. IDF DIABETES ATLAS 2017 [1]. Available from: https://www.diabetesatlas.org/.
5. Taneja A, Su'a B, Hill AG. Efficacy of patient-initiated follow-up clinics in secondary care: a systematic review. Internal medicine journal. 2014;44(12a):1156-60. [http://dx.doi.org/10.1111/imj.12533]
6. Whear R, Abdul-Rahman A-K, Boddy K, Thompson-Coon J, Perry M, Stein K. The clinical effectiveness of patient initiated clinics for patients with chronic or recurrent conditions managed in secondary care: a systematic review. PloS one. 2013;8(10):e74774. [http://dx.doi.org/10.1371/journal.pone.0074774]
7. Administration FAD. Patient-Reported Outcome Measures Use in Medical Product Development to Support Labeling Claims Services USDoHaH; 2009.
8. Hjollund NHI. Fifteen Years' Use of Patient-Reported Outcome Measures at the Group and Patient Levels: Trend Analysis. J Med Internet Res. 2019;21(9):e15856. [http://dx.doi.org/10.2196/15856]
9. Schougaard LMV, Larsen LP, Jessen A, Sidenius P, Dorflinger L, de Thurah A, et al. AmbuFlex: tele-patient-reported outcomes (telePRO) as the basis for follow-up in chronic and malignant diseases. Quality of Life Research. 2016;25(3):525-34. [http://dx.doi.org/10.1007/s11136-015-1207-0]
10. Mejdahl CT, Schougaard LMV, Hjollund NH, Riiskjær E, Thorne S, Lomborg K. PRO-based follow-up as a means of self-management support – an interpretive description of the patient perspective. Journal of Patient-Reported Outcomes. 2018;2(1):1-9. [http://dx.doi.org/10.1186/s41687-018-0067-0]
11. Thurah A, Stengaard-Pedersen K, Axelsen M, Fredberg U, Schougaard LMV, Hjollund NHI, et al. Tele-health Follow-up Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of the Non-inferiority Randomised Controlled Trail (the TeRA study). Arthritis care & research. 2018;0(0). [http://dx.doi.org/10.1002/acr.23280 [doi]]
12. Scholle SH, Morton S, Rodriguez K, Hahn E, Bardach D. Implementation of the PROMIS-29 in Routine Care for People With Diabetes Challenges and Opportunities. The Journal of ambulatory care management. 2018;41(4):274-87. [http://dx.doi.org/10.1097/JAC.0000000000000248]
13. Mejdahl CT, Schougaard LMV, Hjollund NH, Riiskjær E, Lomborg K. Exploring organisational mechanisms in PRO-based follow-up in routine outpatient care - an interpretive description of the clinician perspective. BMC health services research. 2018;18(1):1-12. [http://dx.doi.org/10.1186/s12913-018-3352-y]
14. Speight J, Reaney MD, Barnard KD. Not all roads lead to Rome-a review of quality of life measurement in adults with diabetes. Diabetic medicine : a journal of the British Diabetic Association. 2009;26(4):315-27. [http://dx.doi.org/10.1111/j.1464-5491.2009.02682.x]
15. Shrivastava SR, Shrivastava PS, Ramasamy J. Role of self-care in management of diabetes mellitus. Journal of diabetes and metabolic disorders. 2013;12(1):14. [http://dx.doi.org/10.1186/2251-6581-12-14]
16. Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J. Self-management approaches for people with chronic conditions: a review. Patient education and counseling. 2002;48(2):177-87. [http://dx.doi.org/10.1016/S0738-3991(02)00032-0]
17. Chatterjee S, Davies MJ, Heller S, Speight J, Snoek FJ, Khunti K. Diabetes structured self-management education programmes: a narrative review and current innovations. Lancet Diabetes Endocrinol. 2018;6(2):130-42. [http://dx.doi.org/10.1016/S2213-8587(17)30239-5]
18. Calvert M, Kyte D, Price G, Valderas JM, Hjollund NH. Maximising the impact of patient reported outcome assessment for patients and society. BMJ (Clinical research ed). 2019;364:k5267. [http://dx.doi.org/10.1136/bmj.k5267]
19. Organization WH. Telemedicin: opportunities and developments in Member States: report on the second global survey on eHealth. WHO; 2010.
20. Schougaard LM, Mejdahl CT, Petersen KH, Jessen A, de Thurah A, Sidenius P, et al. Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study. BMC health services research. 2017;17(1):83-017-2015-8. [http://dx.doi.org/10.1186/s12913-017-2015-8 [doi]]
21. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ (Clinical research ed). 2008;337(7680):1223-6. [http://dx.doi.org/10.1136/bmj.a2390]
22. Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT, et al. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. Jama. 2018;319(5):483-94. [http://dx.doi.org/10.1001/jama.2017.21903 [doi]]
23. Tang TS, Yusuf FLA, Polonsky WH, Fisher L. Assessing quality of life in diabetes: II - Deconstructing measures into a simple framework. Diabetes Res Clin Pract. 2017;126:286-302. [http://dx.doi.org/10.1016/j.diabres.2016.10.007]
24. Drennan J. Cognitive interviewing: verbal data in the design and pretesting of questionnaires. Journal of advanced nursing. 2003;42(1):57-63. [http://dx.doi.org/2579 [pii]]
25. Nielsen BK, Lomborg K, Munch-Hansen T, Riiskjær E. Indikatormål for patientinddragelse - teoretiske og metodiske overvejelser [Measures for patient involvement – Theoretical and methodological considerations]. 2015. Contract No.: Report.
26. Maindal HT, Sokolowski I, Vedsted P. Translation, adaptation and validation of the American short form Patient Activation Measure (PAM13) in a Danish version. BMC public health. 2009;9(1):209-. [http://dx.doi.org/10.1186/1471-2458-9-209]
27. Maindal HT, Kayser L, Norgaard O, Bo A, Elsworth GR, Osborne RH. Cultural adaptation and validation of the Health Literacy Questionnaire (HLQ): robust nine-dimension Danish language confirmatory factor model. SpringerPlus. 2016;5(1):1232-016-2887-9. eCollection 016. [http://dx.doi.org/10.1186/s40064-016-2887-9 [doi]]
28. Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelova A, Thomsen HF, et al. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Current medical research and opinion. 2009;25(12):2887-94. [http://dx.doi.org/10.1185/03007990903354674 [doi]]
29. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics. 2009;42(2):377-81. [http://dx.doi.org/10.1016/j.jbi.2008.08.010]
30. Thorne S. Interpretive Description. Qualitative research for applied practice 2, editor. New York and London Routledge 2016 2016.
31. Reaney M, Black P, Gwaltney C. A systematic method for selecting patient-reported outcome measures in diabetes research. Diabetes spectrum : a publication of the American Diabetes Association. 2014;27(4):229-32. [http://dx.doi.org/10.2337/diaspect.27.4.229]
32. World Medical A. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191-4. [http://dx.doi.org/10.1001/jama.2013.281053]