An early interactive human coaching via a mobile application to improve quality of life in patients who underwent gastrectomy for gastric cancer: Design and protocol of a randomized controlled trial (Preprint)

BACKGROUND After gastrectomy, patients may experience the postgastrectomy syndrome and face difficulties adapting to everyday diet. Recently, human health coaching via a mobile application (app) has been used for obese patients or patients with chronic diseases, with significant improvements in clinical outcomes. OBJECTIVE The aim of this study is to evaluate and compare the effects of human health coaching via a mobile app and conventional face-to-face counseling in patients who underwent gastrectomy for gastric cancers. METHODS This study is a single-institution, prospective randomized controlled trial comparing the mobile health and face-to-face counselling groups. After randomization, participants assigned to the mobile health coaching group will receive health coaching via a mobile app for 3 months after discharge, and the assigned coaches will provide personalized advice based on the self-recorded health data. Participants in the face-to-face group will have 1- and 3-months postoperative dietary consultations with a clinical dietitian. The primary endpoint is the food restriction score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-STO22, and secondary endpoints included all other quality of life scale scores and nutritional parameters. The calculated sample size is 180, and the outcomes will be measured until 1-year post-surgery. RESULTS Recruitment started in May, 2020 and currently 51 patients have enrolled in the study. Anticipated date for the completion of enrolment is December 31, 2021 and entire data collection is expected to be completed by December 2022. CONCLUSIONS This study will show the efficacy of human health coaching via a mobile app on dietary adaptation in patients who underwent gastrectomy. A relational approach based on personal data and timely intervention using a mobile platform could reduce patients’ trial and error and improve QoL. CLINICALTRIAL ClinicalTrials.gov, NCT04394585; http://clinicaltrials.gov/ct2/show/NCT040394585

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Individualized Diet and Lifestyle Modifications Reverse Symptoms of Systemic Lupus Erythematosus (Preprint)

10.2196/preprints.11804 ◽

2018 ◽

Author(s):

Daniel Rothman ◽

Faiz Khan ◽

Vanessa Rudin

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Effect Size ◽

Controlled Trial ◽

Health Coaching ◽

Control Group ◽

Sustained Remission ◽

Randomized Controlled ◽

Experimental Group

BACKGROUND There is increasing evidence that digital therapeutic tools can bring personalized medicine to the masses improving outcomes and decreasing cost. Many factors influence the expression of autoimmune disease, and understanding and removing these underlying triggers provides an opportunity to minimize use of medications and some patients can achieve sustained remission if the right triggers for a patient are identified. This randomized controlled trial is the first to test the efficacy of a digital therapeutic intervention which combines adaptive patient generated health data tracking with health coaching to identify factors triggering lupus and to evaluate reductions in symptoms, and improvements in quality of life. OBJECTIVE Evaluate impact of personalized dietary and environmental interventions on quality of life and health care costs. METHODS This a randomized controlled trial using a convenience sample. The Mann-Whitney U test determined that a sample size of 40 patients (20 intervention and 20 control) provides a power of 80% for continuous and ordinal variables. The Bonferroni Correction was used to ensure that the probability of a type 1 error is less than 5% even with the large number of hypotheses being tested. Subjects in both groups received standard of care from their physicians. All subjects repeated the online questionnaires (Fatigue Scale - FACIT, Lupus QOL, and BPI-SF) at weeks 4, 8, 12, and 16. The experimental group going through the mymee protocol received health coaching (weekly calls to educate and implement changes based on data analysis). Digital data collection and tracking was used to correlate dietary/lifestyle/environmental patterns with symptoms. The control group completed the same assessments during the 16 week intervention period but did not receive any additional coaching. The intervention uses correlations between symptoms and triggers that are reported daily to create an iterative cycle of hypotheses tailored to each individual. With 5 min of tracking a day using the app, patients easily report what they have eaten, other triggers, and their symptoms. Using our machine learning platform, coaches identify each patient’s personal disease triggers and help patients implement changes to remove them. RESULTS The interim results of the study showed that 78% improved in the experimental group and 36% in the control group with a P<.01. Furthermore, 67% of the patients have gone off some or all of their drugs after consulting with their doctors. CONCLUSIONS Results show a significant improvement for lupus patients who completed the protocol, demonstrating the potential for digital therapeutics to dramatically improve the quality of life for patients diagnosed not only with lupus, but other chronic diseases (80% of the trial patients also had rheumatoid arthritis). Broad adoption of the mymee intervention could assist in building a database of lupus triggers and symptoms that could lead to further understanding the causes of lupus. Based on interim results, a 78/36 effect size is competitive if not more effective than current drugs in the pipeline like Stelara which shows a 60/31 effect size and includes potential side effects of drug-induced MS and cancer.

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