Abstract
BACKGROUND: Type 2 diabetes mellitus is associated with an increased risk of impaired quality of life. Improving health related quality of life (HRQoL) is therefore an important goal in the multimodal management of diabetes. The aim of this study was to evaluate whether the use of the smartphone app DiaCert, that encourage physical activity by promoting daily steps, also impacts HRQoL in patients with type 2 diabetes. METHODS: In this randomized controlled trial, a total of 181 participants with type 2 diabetes were recruited from six health care centers in Stockholm, Sweden. At baseline, participants were randomized 1:1 to the use of the smartphone app DiaCert for a 3 month physical activity intervention in addition to routine care, or to a control group with routine care only. HRQoL was measured using the RAND-36 questionnaire at baseline and at follow-up after 3 months and 6 months. We analysed the HRQoL scores within the intervention and the control groups, respectively, using the Wilcoxon signed-rank test. Between group differences including intervention effect after the 3 month long intervention and after 6 months of follow-up, were assessed using generalized estimating equation models. RESULTS: In total, 166 participants, 108 men and 58 women, with complete baseline data on RAND-36 were included in analysis. The mean age was 60.2 (SD 11.4) years and the mean Body Mass Index 30.3 (SD 5.4) kg/m(2). The intervention effect, expressed in terms of the difference in change in HRQoL from baseline to follow-up after 3 months of intervention, showed improvement in the health concept role limitations due to physical health problems (- 16.9; 95% CI - 28.5 to - 5.4), role limitations due to emotional problems (- 13.9; 95% CI - 25.8 to - 2.1), and emotional well-being (- 5.7; 95% CI - 10.4 to - 1.0), in the intervention group compared to the control group. No intervention effect was seen at follow-up after 6 months. CONCLUSIONS: Being randomized to use the smartphone app DiaCert promoting physical activity for 3 months, improved aspects of both physical and emotional HRQoL in patients with type 2 diabetes compared to routine care, but the effect did not last 3 months after the intervention ended. Trial Registration ClinicalTrials.gov Identifier: NCT03053336.