Aims/hypothesis There is a lack of e-health systems that integrate the complex variety of aspects relevant for diabetes self-management. We developed and field-tested an e-health system (POWER2DM)... Show moreAims/hypothesis There is a lack of e-health systems that integrate the complex variety of aspects relevant for diabetes self-management. We developed and field-tested an e-health system (POWER2DM) that integrates medical, psychological and behavioural aspects and connected wearables to support patients and healthcare professionals in shared decision making and diabetes self-management.Methods Participants with type 1 or type 2 diabetes (aged >18 years) from hospital outpatient diabetes clinics in the Netherlands and Spain were randomised using randomisation software to POWER2DM or usual care for 37 weeks. This RCT assessed the change in HbA(1c) between the POWER2DM and usual care groups at the end of the study (37 weeks) as a primary outcome measure. Participants and clinicians were not blinded to the intervention. Changes in quality of life (QoL) (WHO-5 Well-Being Index [WHO-5]), diabetes self-management (Diabetes Self-Management Questionnaire - Revised [DSMQ-R]), glycaemic profiles from continuous glucose monitoring devices, awareness of hypoglycaemia (Clarke hypoglycaemia unawareness instrument), incidence of hypoglycaemic episodes and technology acceptance were secondary outcome measures. Additionally, sub-analyses were performed for participants with type 1 and type 2 diabetes separately.Results A total of 226 participants participated in the trial (108 with type 1 diabetes; 118 with type 2 diabetes). In the POWER2DM group (n=111), HbA(1c) decreased from 60.6 +/- 14.7 mmol/mol (7.7 +/- 1.3%) to 56.7 +/- 12.1 mmol/mol (7.3 +/- 1.1%) (means +/- SD, p<0.001), compared with no change in the usual care group (n=115) (baseline: 61.7 +/- 13.7 mmol/mol, 7.8 +/- 1.3%; end of study: 61.0 +/- 12.4 mmol/mol, 7.7 +/- 1.1%; p=0.19) (between-group difference 0.24%, p=0.008). In the sub-analyses in the POWER2DM group, HbA(1c) in participants with type 2 diabetes decreased from 62.3 +/- 17.3 mmol/mol (7.9 +/- 1.6%) to 54.3 +/- 11.1 mmol/mol (7.1 +/- 1.0%) (p<0.001) compared with no change in HbA(1c) in participants with type 1 diabetes (baseline: 58.8 +/- 11.2 mmol/mol [7.5 +/- 1.0%]; end of study: 59.2 +/- 12.7 mmol/mol [7.6 +/- 1.2%]; p=0.84). There was an increase in the time during which interstitial glucose levels were between 3.0 and 3.9 mmol/l in the POWER2DM group, but no increase in clinically relevant hypoglycaemia (interstitial glucose level below 3.0 mmol/l). QoL improved in participants with type 1 diabetes in the POWER2DM group compared with the usual care group (baseline: 15.7 +/- 3.8; end of study: 16.3 +/- 3.5; p=0.047 for between-group difference). Diabetes self-management improved in both participants with type 1 diabetes (from 7.3 +/- 1.2 to 7.7 +/- 1.2; p=0.002) and those with type 2 diabetes (from 6.5 +/- 1.3 to 6.7 +/- 1.3; p=0.003) within the POWER2DM group. The POWER2DM integrated e-health support was well accepted in daily life and no important adverse (or unexpected) effects or side effects were observed.Conclusions/interpretation POWER2DM improves HbA(1c) levels compared with usual care in those with type 2 diabetes, improves QoL in those with type 1 diabetes, improves diabetes self-management in those with type 1 and type 2 diabetes, and is well accepted in daily life.Trial registration ClinicalTrials.gov NCT03588104.Funding This study was funded by the European Union's Horizon 2020 Research and Innovation Programme (grant agreement number 689444). Show less
Purpose The diagnosis and treatment of cancer negatively affect patients' physical, functional and psychological wellbeing. Patients' needs for care cannot be addressed unless they are recognized... Show morePurpose The diagnosis and treatment of cancer negatively affect patients' physical, functional and psychological wellbeing. Patients' needs for care cannot be addressed unless they are recognized by healthcare providers (HCPs). The use of quality of life (QoL) assessments with feedback to HCPs might facilitate the identification and discussion of QoL-topics. Methods 113 patients with stage I-IIIB breast cancer treated with chemotherapy were included in this randomized controlled trial. Patients were randomly allocated to receive either usual care, or usual care with an intervention consisting of a QoL-monitor assessing QoL, distress and care needs before every chemotherapy cycle visit. Patients completed questionnaires regarding QoL, illness perceptions, self-efficacy, and satisfaction with communication. From the 2nd visit onwards, patients in the intervention arm and their HCPs received a copy of the QoL overview and results were shown in patients' medical files. Audio-recordings and patients' self-reports were used to investigate effects on communication, patient management and patient-wellbeing. A composite score for communication was calculated by summing the number of QoL-topics discussed during each consultation. Results Use of the QoL-monitor resulted in a higher communication score (0.7 topics increase per visit,p = 0.04), especially regarding the disease-specific and psychosocial issues (p < 0.01). There were no differences in patient management, QoL, illness perceptions or distress. Patients in the experimental arm (n = 60) had higher scores on satisfaction with communication (p < 0.05). Conclusions Use of a QoL-monitor during chemotherapy in patients with early breast cancer might result in a more frequent discussion of QoL-topics, associated with high levels of patients' satisfaction. Show less
The thesis reports about the effects of music therapy with patients in the late stage of Huntington's disease. A literature review, a focus group study, a randomized controlled trial, an... Show moreThe thesis reports about the effects of music therapy with patients in the late stage of Huntington's disease. A literature review, a focus group study, a randomized controlled trial, an evaluation for complex interventions and a case report study are integrated in the thesis. The beneficial effects of music therapy could not be proven with the RCT-design and outcome measures that have been used. The beneficial effects of music therapy could not be proven with the RCT-design and outcome measures that have been used in the effect study. This outcome could imply that either music therapy is not effective in HD, or that the chosen study design or the primary endpoints (communication and expressive skills and behavior) were not appropriate to show the effectiveness of music therapy. A process evaluation of the RCT was executed to elucidate the results and to investigate how the study was performed. Show less
