scholarly journals Health-Related Quality of Life Improvements in Systemic Lupus Erythematosus Derived from a Digital Therapeutic Plus Tele-Health Coaching Intervention: Randomized Controlled Pilot Trial (Preprint)

2020 ◽  
Author(s):  
Faiz Khan ◽  
Nora Granville ◽  
Raja Malkani ◽  
Yash Chathampally

BACKGROUND Systemic lupus erythematosus (SLE), a systemic autoimmune disease with no known cure, remains poorly understood and patients suffer from many gaps in care. Recent work has suggested that dietary and other lifestyle factors play an important role in triggering and propagating SLE in some susceptible individuals. However, the magnitude of influence of these triggers, how to identify pertinent triggers in individual patients, and whether removing these triggers confers clinical benefit is unknown. OBJECTIVE To demonstrate that a digital therapeutic intervention, utilizing a mobile app that allows self-tracking of dietary, environmental, and lifestyle triggers, paired with telehealth coaching, added to usual care, improves quality of life in patients with SLE compared with usual care alone. METHODS In this randomized controlled pilot study, adults with SLE were assigned to a 16-week digital therapeutic intervention plus usual care or usual care alone. Primary outcome measures were changes from baseline to 16 weeks on 3 validated health-related quality of life (HRQoL) tools: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Pain Inventory-Short Form (BPI-SF), and Lupus Quality of Life (LupusQoL). RESULTS A total of 50 patients were randomized (23 control, 27 intervention). In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs –1% for the control group, <i>P</i>&lt;.001), BPI-SF-Pain Interference (25% vs 0%, <i>P</i>=.02), LupusQoL-Planning (17% vs 0%, <i>P</i>=.004), LupusQoL-Pain (13% vs 0%, <i>P</i>=.004), LupusQoL-Emotional Health (21% vs 4%, <i>P</i>=.02), and LupusQoL-Fatigue (38% vs 13%, <i>P</i>&lt;.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs –6%, <i>P</i>=.049), LupusQoL-Physical Health (17% vs 3%, <i>P</i>=.049), and LupusQoL-Burden to Others (33% vs 4%, <i>P</i>=.04) were significant at an unadjusted 5% significance level. CONCLUSIONS A digital therapeutic intervention that pairs self-tracking with telehealth coaching to identify and remove dietary, environmental, and lifestyle symptom triggers resulted in statistically significant, clinically meaningful improvements in HRQoL when added to usual care in patients with SLE. CLINICALTRIAL ClinicalTrials.gov NCT03426384; https://clinicaltrials.gov/ct2/show/NCT03426384

10.2196/23868 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e23868
Author(s):  
Faiz Khan ◽  
Nora Granville ◽  
Raja Malkani ◽  
Yash Chathampally

Background Systemic lupus erythematosus (SLE), a systemic autoimmune disease with no known cure, remains poorly understood and patients suffer from many gaps in care. Recent work has suggested that dietary and other lifestyle factors play an important role in triggering and propagating SLE in some susceptible individuals. However, the magnitude of influence of these triggers, how to identify pertinent triggers in individual patients, and whether removing these triggers confers clinical benefit is unknown. Objective To demonstrate that a digital therapeutic intervention, utilizing a mobile app that allows self-tracking of dietary, environmental, and lifestyle triggers, paired with telehealth coaching, added to usual care, improves quality of life in patients with SLE compared with usual care alone. Methods In this randomized controlled pilot study, adults with SLE were assigned to a 16-week digital therapeutic intervention plus usual care or usual care alone. Primary outcome measures were changes from baseline to 16 weeks on 3 validated health-related quality of life (HRQoL) tools: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Pain Inventory-Short Form (BPI-SF), and Lupus Quality of Life (LupusQoL). Results A total of 50 patients were randomized (23 control, 27 intervention). In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs –1% for the control group, P<.001), BPI-SF-Pain Interference (25% vs 0%, P=.02), LupusQoL-Planning (17% vs 0%, P=.004), LupusQoL-Pain (13% vs 0%, P=.004), LupusQoL-Emotional Health (21% vs 4%, P=.02), and LupusQoL-Fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs –6%, P=.049), LupusQoL-Physical Health (17% vs 3%, P=.049), and LupusQoL-Burden to Others (33% vs 4%, P=.04) were significant at an unadjusted 5% significance level. Conclusions A digital therapeutic intervention that pairs self-tracking with telehealth coaching to identify and remove dietary, environmental, and lifestyle symptom triggers resulted in statistically significant, clinically meaningful improvements in HRQoL when added to usual care in patients with SLE. Trial Registration ClinicalTrials.gov NCT03426384; https://clinicaltrials.gov/ct2/show/NCT03426384


2017 ◽  
Vol 45 (4) ◽  
pp. 452-458
Author(s):  
Birgitta Ojala ◽  
Clas-Håkan Nygård ◽  
Heini Huhtala ◽  
Seppo T. Nikkari

The aim of this study was to evaluate the effectiveness of vocationally outpatient oriented rehabilitation on an intervention group, compared with a control group that did not take part in the intervention. The groups were compared for health-related quality of life (HRQoL) by the quantitative indicator RAND 36. Data were obtained by a self-report at baseline and at nine months follow-up. Differences between base-line and follow-up were analyzed within group and between the groups. The study population consisted of 751 municipal employees aged between 26 and 64 years; an intervention with 463 women and 115 men ( n = 578), and a control group with 138 women and 35 men ( n = 173). In this study we focused on those who had answered to all questions in RAND 36, thus 581 remained. Of these, 388 were in the intervention group (mean age 49.0 years) and 110 in the control group (mean age 48.4 years). Intervention was based on cognitive behavioral therapy. Participants in the 9-month outpatient intervention group showed statistically significant increase in all eight RAND 36 areas. Most improvement was seen in the psychosocial functioning index ( p = 0.002). Although there were no statistically significant changes in RAND 36 components in the control group, difference in changes between groups were seen in energy and fatigue ( p < 0.001), social functioning ( p = 0.032) and general health perceptions 0.027 in favor of the intervention group. The results suggest that a cognitive behavioral intervention as an early rehabilitation program is effective in increasing employees’ quality of life, as measured by RAND 36.


2021 ◽  
Author(s):  
David Rudilla ◽  
Salvador Perelló ◽  
Pedro Landete ◽  
Enrique Zamora ◽  
María Vázquez ◽  
...  

Abstract Purpose The aim was to determine adherence to CPAP and health-related outcomes in patients with OSA via a comprehensive program based on stratification and individualized care plans, including motivational interview. Methods A multicentre, randomized controlled trial (RCT) design was used in 3 hospitals. The control group followed the usual treatment. Intervention group (PIMA) followed the treatment with an adapted care plan (home visits, telephone, care-center) depending on socio-demographic, clinical and psychological variables, using motivational interviews in all the interventions. The main outcome was adherence, and secondary were quality of life, emotional state, activities, social relationships, perceived competence, and motivation. The clinical trial was registered with www.clinicaltrials.gov (NCT 04691479). Results 213 patients (68.1% men, 58.7% between 51–69 years old, 45.5% upper-secondary school education) were randomized: 108 were in the intervention group and 105 were in the control group. The result showed a statistically significant difference in adherence at 90 and 180 days respectively: 129.24 (IC 95% 77.25-181.22) p < 0.0001 and 288.30 (IC95% 187.146–389.47) p < 0.0001. The adherence (hours/day) showed favourable results for the PIMA group compared to the control group at 90 days with a difference of 1.74 hours/day (IC95% 1.18–2.30) p < 0.0001 and at 180 days with a difference of 2.31 (IC95% 1.72–2.91) p < 0.001. The results for secondary outcomes also showed statistically significant differences in favour of the PIMA group. Conclusions This study found evidence that a program based on stratification and personalized care plans, through motivational interviewing, improves adherence to CPAP treatment and health-related outcomes than traditional care.


2021 ◽  
Author(s):  
Yuqing Song ◽  
Xia Xie ◽  
Yanlin Chen ◽  
Ying Wang ◽  
Hui Yang ◽  
...  

Abstract Background: Ankylosing spondylitis(AS), as a common inflammatory rheumatic disease, often cause depression and impaired health-related quality of life(QoL). Although positive effects of patient education have been demonstrated, limited studies explored the benefits of education via mobile applications for AS patients. This study aimed to evaluate the effects of the WeChat-based educational intervention on depression and health-related QoL in AS patients.Methods: We conducted a single-blind randomized controlled trial from March to December 2017. Potential patients were recruited and randomized into the intervention group who received a 12-week WeChat-based educational intervention (consisting of four individual online educational sessions, online health information) or the control group receiving standard care. Data was collected at baseline and 12 weeks after the intervention. Outcomes were measured by Beck Depression Inventory-Ⅱ, the Medical Outcomes Study Short Form 36-item Health Survey, Bath Ankylosing Spondylitis Patient Global Score, visual analogue scales. Results: A total of 118 patients with AS were included and analysed. Measures at baseline were comparable between groups. After the intervention, the intervention group reported significant higher scores of all dimensions of QoL except for physical function and validity, compared with the control group. Additionally, patients in the intervention group had lower depressive symptom than the control group. No significant difference in other outcomes was observed at 12 weeks. Conclusions: This study found that the 12-week educational intervention via WeChat had positive effects on reducing depressive symptom and improving health related QoL in Chinese patients with AS. We suggest that this intervention can be integrated into current routine care of AS patients. Trial registration: Chinese Clinical Trail Registry (registry number: ChiCTR-IPR-16009293). Registered September 29, 2016.


2019 ◽  
Vol 33 (9) ◽  
pp. 1431-1444 ◽  
Author(s):  
Tove Lindhardt ◽  
Susan Mai Loevgreen ◽  
Brigitte Bang ◽  
Catja Bigum ◽  
Tobias W Klausen

Objective: The aim of this study was to test and compare the effect of (1) a systematic discharge assessment with targeted advice and (2) a motivational interview followed by a home visit. Design: This was a three-armed randomized controlled study. Setting: This study was conducted in the Medical department in a university hospital. Subjects: Patients ⩾65 years of age with health problems at discharge participated in the study. Interventions: Group A ( n = 117): patients were informed of health problems and self-care interventions; Group B ( n = 116): a motivational conversation targeting activities of daily living with a home care nurse and a home visit. Main measures: The main measures of this study were readmissions, handgrip strength, chair-to-stand test, health-related quality of life, depression signs, mortality, and call on municipality services. Results: Risk of readmission was reduced for intervention groups by 30% (A; P = 0.26) and 22 % (B; P = 0.46). Mean number of days to first readmission was 49.5 (±51.0) days for the control group ( n = 116) and 57.9 (±53.6) and 67.2 (±58.1) days for the intervention groups A ( P  = 0.43) and B ( P  = 0.10), respectively. Mean loss of handgrip strength was 10.6 (±16.6) kg for men in the control group and 7 (±19.2) and 1.4 (±17.1) kg for the intervention groups A ( P  = 0.38) and B ( P  = 0.01), respectively. Health-related quality of life improved with 0.3 (±23.7) points in the control group and 7.4 (±24.4) and 3.2 (±22.3) points in the intervention groups A ( P = 0.04) and B ( P  = 0.37), respectively. In total, 17 (16.3%) in the control group were provided with assistive devices after three months and 8 (7.3%) and 19 (17.6%) in the intervention groups A ( P = 0.04) and B ( P  = 0.81), respectively. Conclusion: The interventions reduced the risk of readmission and improved handgrip strength, quality of life, and use of assistive devices.


Neurology ◽  
2020 ◽  
Vol 95 (3) ◽  
pp. e239-e246 ◽  
Author(s):  
Valentina Franco ◽  
Maria Paola Canevini ◽  
Giovambattista De Sarro ◽  
Cinzia Fattore ◽  
Guido Fedele ◽  
...  

ObjectiveTo determine whether systematic screening for adverse effects of antiepileptic drugs (AEDs) reduces toxicity burden and improves health-related quality of life in patients with epilepsy.MethodsConsecutive patients with uncontrolled seizures aged ≥16 years and a high Adverse Event Profile (AEP) score were randomized to 2 groups and followed up for 18 months at 11 referral centers. AEP scores were made available to treating physicians at all visits in the intervention group, but not in the control group. Co–primary endpoints were changes in AEP scores and Quality of Life Inventory for Epilepsy-31 (QOLIE–31) scores.ResultsOf 809 enrolled patients able to complete the AEP questionnaire, 222 had AEP scores ≥45 and were randomized to the intervention (n = 111) or control group (n = 111). A total of 206 patients completed the 18-month follow-up. Compared with baseline, AEP scores decreased on average by 7.2% at 6 months, 12.1% at 12 months, and 13.8% at 18 months in the intervention group (p < 0.0001), and by 7.7% at 6 months, 9.2% at 12 months, and 12.0% at 18 months in controls (p < 0.0001). QOLIE-31 scores also improved from baseline to final visit, with a mean 20.7% increase in the intervention group and a mean 24.9% increase in the control group (p < 0.0001). However, there were no statistically significant differences in outcomes between groups for the 2 co–primary variables.ConclusionsContrary to findings from a previous study, systematic screening for adverse effects of AEDs using AEP scores did not lead to a reduced burden of toxicity over usual physician treatment.Italian Medicines Agency (AIFA) identifierFARM52K2WM_003.Clinicaltrials.gov identifierNCT03939507 (registered retrospectively in 2019; the study was conducted during the 2006–2009 period and registration of clinical trials was not a widely established practice when this study was initiated).Classification of evidenceThis study provides Class II evidence that the additional collection of formal questionnaires regarding adverse effects of AEDs does not reduce toxicity burden over usual physician treatment.


2019 ◽  
Author(s):  
Chi-Wen Kao ◽  
Ting-Yu Chen ◽  
Shu-Meng Cheng ◽  
Wei-Shiang Lin ◽  
Yue-Cune Chang

BACKGROUND Hypertension is a major cause of mortality in cardiac, vascular, and renal disease. Effective control of elevated blood pressure has been shown to reduce target organ damage. A Web-based self-titration program may empower patients to control their own disease, share decisions about antihypertensive dose titration, and improve self-management, ultimately improving health-related quality of life. OBJECTIVE Our primary aim was to evaluate the effects of a Web-based self-titration program for improving blood pressure control in patients with primary hypertension. Our secondary aim was to evaluate the effects of that program on improving health-related quality of life. METHODS This was a parallel-group, double-blind, randomized controlled trial with assessments at baseline, 3 months, and 6 months. We included patients with primary hypertension (blood pressure&gt;130/80 mm Hg) from a cardiology outpatient department in northern Taiwan and divided them randomly into intervention and control groups. The intervention group received the Web-based self-titration program, while the control group received usual care. The random allocation was concealed from participants and outcome evaluators. Health-related quality of life was measured by the EuroQol five-dimension self-report questionnaire. We used generalized estimating equations to evaluate the effects of the intervention. RESULTS We included 222 patients and divided them equally into intervention (n=111) and control (n=111) groups. Patients receiving the Web-based self-titration program showed significantly greater improvement in the systolic and diastolic blood pressure control than those who did not receive this program, at 3 months (–21.4 mm Hg and –5.4 mm Hg, respectively; <italic>P</italic>&lt;.001) and 6 months (–27.8 mm Hg and –9.7 mm Hg, respectively; <italic>P</italic>&lt;.001). Compared with the control group, the intervention group showed a significant decrease in the overall defined daily dose at both 3 (–0.202, <italic>P</italic>=.003) and 6 (–0.236, <italic>P</italic>=.001) months. Finally, health-related quality of life improved significantly in the intervention group compared with the control group at both 3 and 6 months (both, <italic>P</italic>&lt;.001). CONCLUSIONS A Web-based self-titration program can provide immediate feedback to patients about how to control their blood pressure and manage their disease at home. This program not only decreases mean blood pressure but also increases health-related quality of life in patients with primary hypertension. CLINICALTRIAL ClinicalTrials.gov NCT03470974; https://clinicaltrials.gov/ct2/show/NCT03470974


2019 ◽  
Vol 8 ◽  
Author(s):  
Roline Y. Barnes ◽  
Jennifer Jelsma ◽  
Romy Parker

Background: Musculoskeletal diseases consume a large amount of health and social resources and are a major cause of disability in both low- and high-income countries. In addition, patients frequently present with co-morbid chronic diseases of lifestyle. The area of musculoskeletal disease is restricted by a lack of epidemiological knowledge, particularly in low- and middle-income countries.Objectives: This pragmatic randomised controlled trial assessed the benefits of a 6-week physiotherapy intervention for middle-aged women with musculoskeletal conditions compared to usual care.Method: A weekly 2-h educational programme utilising a workbook, discussion group and exercise class was presented for the intervention group, while the control group received usual care. The primary outcome was health-related quality of life. Parametric and non-parametric data were used to determine the equivalence between the groups.Results: Twenty-two participants were randomised to the intervention and 20 to the control group. The control group demonstrated no within-group improvement in health-related quality of life items, compared to significant improvements in two items in the intervention group. The change in median utility score within the intervention group was twice as large as the change in the control group. With regard to self-efficacy, the intervention group demonstrated significant within-group changes in perceived management of fatigue and discomfort.Conclusion: The positive impact of the intervention on the participants suggests that the programme should continue at the clinic in question, but should be presented at a more convenient time for participants who work, as recruitment to the study was less than anticipated. Primary health care systems in South Africa urgently need to put structures in place for effective management of the functional impact of chronic diseases of lifestyle and musculoskeletal conditions. It is time for physiotherapists and possibly other health care professionals to participate in the development of appropriate community level interventions to address the functioning and quality of life of individuals living with the diseases.


10.2196/15836 ◽  
2019 ◽  
Vol 21 (12) ◽  
pp. e15836 ◽  
Author(s):  
Chi-Wen Kao ◽  
Ting-Yu Chen ◽  
Shu-Meng Cheng ◽  
Wei-Shiang Lin ◽  
Yue-Cune Chang

Background Hypertension is a major cause of mortality in cardiac, vascular, and renal disease. Effective control of elevated blood pressure has been shown to reduce target organ damage. A Web-based self-titration program may empower patients to control their own disease, share decisions about antihypertensive dose titration, and improve self-management, ultimately improving health-related quality of life. Objective Our primary aim was to evaluate the effects of a Web-based self-titration program for improving blood pressure control in patients with primary hypertension. Our secondary aim was to evaluate the effects of that program on improving health-related quality of life. Methods This was a parallel-group, double-blind, randomized controlled trial with assessments at baseline, 3 months, and 6 months. We included patients with primary hypertension (blood pressure>130/80 mm Hg) from a cardiology outpatient department in northern Taiwan and divided them randomly into intervention and control groups. The intervention group received the Web-based self-titration program, while the control group received usual care. The random allocation was concealed from participants and outcome evaluators. Health-related quality of life was measured by the EuroQol five-dimension self-report questionnaire. We used generalized estimating equations to evaluate the effects of the intervention. Results We included 222 patients and divided them equally into intervention (n=111) and control (n=111) groups. Patients receiving the Web-based self-titration program showed significantly greater improvement in the systolic and diastolic blood pressure control than those who did not receive this program, at 3 months (–21.4 mm Hg and –5.4 mm Hg, respectively; P<.001) and 6 months (–27.8 mm Hg and –9.7 mm Hg, respectively; P<.001). Compared with the control group, the intervention group showed a significant decrease in the overall defined daily dose at both 3 (–0.202, P=.003) and 6 (–0.236, P=.001) months. Finally, health-related quality of life improved significantly in the intervention group compared with the control group at both 3 and 6 months (both, P<.001). Conclusions A Web-based self-titration program can provide immediate feedback to patients about how to control their blood pressure and manage their disease at home. This program not only decreases mean blood pressure but also increases health-related quality of life in patients with primary hypertension. Trial Registration ClinicalTrials.gov NCT03470974; https://clinicaltrials.gov/ct2/show/NCT03470974


Author(s):  
Ove Karlsson ◽  
Therese Karlsson ◽  
Nina Pauli ◽  
Paulin Andréll ◽  
Caterina Finizia

Abstract Purpose This study aims to examine effects of jaw exercise on trismus 3 years following completion of a post-radiotherapy jaw exercise intervention. Methods Prospective study including 50 patients with head-and-neck cancer receiving radiotherapy and/or chemotherapy, plus a matched control group. The intervention group underwent 10 weeks of jaw exercise training. Patients were followed pre-and postintervention and 3 years postintervention completion. Outcome measures were maximal interincisal opening (MIO), trismus-related symptoms, and health-related quality-of-life as measured by Gothenburg Trismus Questionnaire, EORTC QLQ-C30, and EORTC QLQ-H&N35. Results The intervention group had a statistically significantly higher mean MIO compared with the control group (40.1 mm and 33.9 mm, respectively, p < 0.001), reported less trismus-related problems and had an improved health-related quality-of-life when compared with the control group at the 3-year follow-up. These differences were all statistically significant. Conclusion Jaw exercise therapy resulted in increased MIO, less trismus-related symptoms, and improved health-related quality-of-life. Jaw exercise therapy should be initiated early, in a structured manner and continued long-term.


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