Iversen MM, Igland J, Smith-Strøm H, Østbye T, Tell GS, Skeie S, Cooper JG, Peyrot M, Graue M, et al.
BMC endocrine disorders. Date of publication 2020 Oct 21;volume 20(1):157.
1. BMC Endocr Disord. 2020 Oct 21;20(1):157. doi: 10.1186/s12902-020-00637-x.
Effect of a telemedicine intervention for diabetes-related foot ulcers on health,
well-being and quality of life: secondary outcomes from a cluster randomized
controlled trial (DiaFOTo).
Iversen MM(1)(2), Igland J(3)(4), Smith-Strøm H(3)(5), Østbye T(4)(6), Tell
GS(4), Skeie S(7), Cooper JG(5), Peyrot M(3)(8), Graue M(3).
Author information:
(1)Faculty of Health and Social Sciences, Department of Health and Caring
Sciences, Western Norway University of Applied Sciences, N-5020, Bergen, Norway.
miv@hvl.no.
(2)Department of Medicine, Section of Endocrinology, Stavanger University
Hospital, Stavanger, Norway. miv@hvl.no.
(3)Faculty of Health and Social Sciences, Department of Health and Caring
Sciences, Western Norway University of Applied Sciences, N-5020, Bergen, Norway.
(4)Department of Global Public Health and Primary Care, University of Bergen,
Bergen, Norway.
(5)Department of Medicine, Section of Endocrinology, Stavanger University
Hospital, Stavanger, Norway.
(6)Duke Global Health Institute, Duke University, Durham, NC, USA.
(7)Department of Research, Stavanger University Hospital, Stavanger, Norway.
(8)Department of Sociology, Loyola University Maryland, Baltimore, MD, USA.
BACKGROUND: Follow-up care provided via telemedicine (TM) is intended to be a
more integrated care pathway to manage diabetes-related foot ulcers (DFU) than
traditionally-delivered healthcare. However, knowledge of the effect of TM
follow-up on PROMs including self-reported health, well-being and QOL in patients
with DFUs is lacking and often neglected in RCT reports in general. Therefore, in
this study of secondary outcomes from the DiaFOTo trial, the aim was to compare
changes in self-reported health, well-being and QOL between patients with DFUs
receiving telemedicine follow-up care in primary healthcare in collaboration with
specialist healthcare, and patients receiving standard outpatient care.
METHODS: The current study reports secondary endpoints from a cluster randomized
controlled trial whose primary endpoint was ulcer healing time. The trial
included 182 adults with diabetes-related foot ulcers (94/88 in the
telemedicine/standard care groups) in 42 municipalities/districts, recruited from
three clinical sites in Western Norway. Mean (SD) diabetes duration for the study
population was 20.8 (15.0). The intervention group received care in the community
in collaboration with specialist healthcare using an asynchronous telemedicine
intervention. The intervention included an interactive web-based ulcer record and
a mobile phone enabling counseling and communication between the community nurses
and specialist healthcare; the control group received standard outpatient care.
In total 156 participants (78/78) reported on secondary endpoints: self-reported
health, well-being and quality of life evaluated by generic and disease-specific
patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and
Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot
Ulcer-Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects
regression was used to investigate possible differences in changes in the scores
between the intervention and control group at the end of follow-up.
RESULTS: In intention to treat analyses, differences between treatment groups
were small and non-significant for the health and well-being scale scores, as
well as for diabetes-related distress and foot ulcer-specific quality of life.
CONCLUSIONS: There were no significant differences in changes in scores for the
patient reported outcomes between the intervention and control group, indicating
that the intervention did not affect the participants' health, well-being and
quality of life.
TRIAL REGISTRATION: Clinicaltrials.gov , NCT01710774 . Registered October 19th,
2012.
DOI: 10.1186/s12902-020-00637-x
PMCID: PMC7580005
PMID: 33087074
