POS0844 EFFECTS OF SERIAL LOCALLY APPLIED WATER-FILTERED INFRARED A RADIATION IN PATIENTS WITH SYSTEMIC SCLEROSIS WITH SEVERE RAYNAUD’S SYNDROME RECEIVING PROSTAGLANDINE TREATMENT – A RANDOMIZED CONTROLLED TRIAL

Background:More than 95% of patients with systemic sclerosis (SSc) suffer from Raynaud’s syndrome (RS) leading to digital ulcerations (DU). In severe RS, intravenous application of prostaglandins is required. Moreover, these patients profit from an additional non-pharmacological treatment using hyperthermia to increase vasodilatation and perfusion, and to reduce pain.Serial locally applied water-filtered infrared A radiation (sl-wIRAR) is a hyperthermia treatment modality using infrared heat radiation in the range of 780-1400nm with high tissue penetration and low thermal load on the skin surface [1]. wIRAR has both, temperature-dependent and non-dependent effects, which do not inherit thermal energy transfer and/or relevant temperature changes [1]. It is therefore not only used in acute and chronic wound healing as it promotes perfusion, alleviates pain and has anti-infectious effects [2], but is also used in oncology [3] and rheumatology [4].Objectives:We conducted a randomized controlled trial with a follow-up visit after 2 weeks to evaluate the value of a high-frequent hyperthermia treatment using sl-wIRAR in comparison to a low-frequent hyperthermia treatment (our standard) in SSc patients with severe RS receiving Iloprost treatment.Methods:Eligible patients had SSc according to the 2013 ACR/EULAR classification criteria, were 18 to 80 years old and had RS requiring treatment with Iloprost in an in-patient setting. Key exclusion criteria were contraindications to any hyperthermia treatment such as infection or heat insensitivity. The trial was conducted at Campus Kerckhoff of Justus-Liebig University Giessen. Eligible patients were equally randomized to the intervention group (IG) receiving additional sl-wIRAR treatment (2 treatments for 30 min per day for 8 days) plus the standard of care (Iloprost treatment over 8 days plus daily carbon dioxide hand baths of 20 min) and the control group (CG) receiving only the standard of care. Primary outcome was the between-group difference in pain measured on a numeric rating scale (NRS) after intervention. Key secondary outcomes included a change in RS frequency, RS duration, and a change in Interleukin (IL) -6 and VEGF levels.Results:From 01.03.2020 to 31.12.2020 49 SSc patients met the inclusion criteria. 42 patients were enrolled (IG: 21, CG: 21). 38 patients (IG:19, CG: 19) completed the full trial period and were analyzed. There was no statistically significant between-group difference in pain levels (NRS) (p=0.284, Z -1.082 (Mann-Whitney U Test)) and thus the primary outcome was not met. Therefore, all p values for secondary outcomes are nominal. Intensity (Visual analogue scale 0-100mm) and duration (min) of RS were reduced in the IG (mean ± standard error) -14.579 ± 7.214 mm (p=0.058) and -2.917 ± 1.510 min (p=0.08), respectively. Intra- and inter-group comparison of IL-6 and VEGF levels showed no relevant change.Conclusion:The additive and frequent use of sl-wIRAR in the treatment of SSc patients with RS requiring Iloprost treatment does not improve outcomes regarding pain levels, RS intensity or frequency nor IL-6 and VEGF levels when compared to Iloprost treatment and low-frequent hyperthermia application.References:[1]Hoffmann G. Clinical applications of water-filtered infrared-A (wIRA) – a review. Phys Med Rehab Kuror. 2017;27(05):265–274.[2]Hoffmann G, Harte M, Mercer JB. Heat for wounds – water-fil- tered infrared-a (wIRA) for wound healing – a review. GMS Ger Med Sci. 2016;14:Doc08.[3]Notter M, Thomsen AR, Nitsche M, et al. Combined wIRA-hyperthermia and hypofractionated re-irradiation in the treatment of locally recurrent breast cancer: evaluation of therapeutic outcome based on a novel size classification. Cancers (Basel). 2020;12(3): 606.[4]Klemm P, Eichelmann M, Aykara I et al. Serial locally applied water-filtered infrared a radiation in axial spondyloarthritis – a randomized controlled trial, International Journal of Hyperthermia, 37:1, 965-970.Acknowledgements:We acknowledge the help of Carina Schreiyäck.This study was in part supported by the Dr. med. h.c. Erwin Braun Foundation, Basel, a charitable, nonprofit Swiss scientific foundation approved by the Swiss Federal Administration. The foundation supports clinical investigation of waterfiltered infrared-A. The foundation was not involved in any content- or decision-related aspect of the study.This study was prospectively registered at www.drks.de (German Registry of Clinical Studies): DRKS00021098Disclosure of Interests:None declared

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Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04354-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Aaron Gazendam ◽

◽

Seper Ekhtiari ◽

Nolan S. Horner ◽

Nicole Simunovic ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Pain Control ◽

Shoulder Arthroscopy ◽

Controlled Trial ◽

Arthroscopic Surgery ◽

Standard Of Care ◽

Opioid Prescription ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Arthroscopic Knee

Abstract Background Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250).

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A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

Scientific Reports ◽

10.1038/s41598-021-92242-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Lara Bücker ◽

Josefine Gehlenborg ◽

Steffen Moritz ◽

Stefan Westermann

Keyword(s):

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Primary Outcome ◽

Controlled Trial ◽

Group Differences ◽

Control Group ◽

Gambling Problems ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

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An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/14648 ◽

2019 ◽

Vol 6 (10) ◽

pp. e14648 ◽

Cited By ~ 9

Author(s):

Peter Johansson ◽

Mats Westas ◽

Gerhard Andersson ◽

Urban Alehagen ◽

Anders Broström ◽

...

Keyword(s):

Cardiovascular Disease ◽

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Primary Outcome ◽

Behavioral Therapy ◽

Controlled Trial ◽

Cognitive Behavioral ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Eq Vas

Background Depression is a common cause of reduced well-being and prognosis in patients with cardiovascular disease (CVD). However, there is a lack of effective intervention strategies targeting depression. Objective The study aimed to evaluate the effects of a nurse-delivered and adapted internet-based cognitive behavioral therapy (iCBT) program aimed at reducing depression in patients with CVD. Methods A randomized controlled trial was conducted. A total of 144 patients with CVD with at least mild depression (Patient Health Questionnaire–9 [PHQ-9] score ≥5) were randomized 1:1 to a 9-week program of iCBT (n=72) or an active control participating in a Web-based discussion forum (online discussion forum [ODF], n=72). The iCBT program, which included 7 modules, was adapted to fit patients with CVD. Nurses with an experience of CVD care provided feedback and a short introduction to cognitive behavioral therapy. The primary outcome, depression, was measured using PHQ-9. Secondary outcomes were depression measured using the Montgomery-Åsberg Depression Rating Scale–self-rating version (MADRS-S), health-related quality of life (HRQoL) measured using Short Form 12 (SF-12) survey and EuroQol Visual Analogue Scale (EQ-VAS), and the level of adherence. An intention-to-treat analysis with multiple imputations was used. Between-group differences in the primary and secondary outcomes were determined by the analysis of covariance, and a sensitivity analysis was performed using mixed models. Results Compared with ODF, iCBT had a significant and moderate treatment effect on the primary outcome depression (ie, PHQ-9; mean group difference=−2.34 [95% CI −3.58 to −1.10], P<.001, Cohen d=0.62). In the secondary outcomes, compared with ODF, iCBT had a significant and large effect on depression (ie, MADRS-S; P<.001, Cohen d=0.86) and a significant and moderate effect on the mental component scale of the SF-12 (P<.001, Cohen d=0.66) and the EQ-VAS (P<.001, Cohen d=0.62). Overall, 60% (n=43) of the iCBT group completed all 7 modules, whereas 82% (n=59) completed at least half of the modules. No patients were discontinued from the study owing to a high risk of suicide or deterioration in depression. Conclusions Nurse-delivered iCBT can reduce depression and improve HRQoL in patients with CVD, enabling treatment for depression in their own homes and at their preferred time. Trial Registration ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074

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GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3738-0 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Valentin Garyga ◽

Florian Pochelu ◽

Béatrice Thivichon-Prince ◽

Walid Aouini ◽

Julie Santamaria ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Behavior Change ◽

Motivational Interviewing ◽

Oral Hygiene ◽

Controlled Trial ◽

Standard Of Care ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Personalized Video

Abstract Background Oral hygiene is of paramount importance for the preservation of oral health, and for patients affected by periodontal disease establishing an effective oral hygiene routine is the first step of therapy. Several clinical frameworks have been developed to foster behavior change, such as motivational interviewing. However, two obstacles can be identified. First, patients tend to forget the advice they were given during the consultation. Second, it is hard to maintain motivation in the long term, thus leading to relapse. An innovative eHealth solution was designed with the aim to tackle both obstacles and supplement the current clinical standard of care. The primary objective is to compare the full mouth plaque scores of study groups (eHealth plus standard of care versus standard of care only) at 8 weeks of follow up. The main secondary objective is to compare the full mouth bleeding score at 8 weeks of follow up. Methods/design The “GoPerio” study is a multicenter, randomized, controlled trial assessing the impact of a novel eHealth concept for oral hygiene motivation (personalized video of oral hygiene routine available for the patient via a cloud server plus interactive text messages) in addition to the current standard of care (motivational interviewing plus tooth scaling and polishing). The minimum sample size required is 86 patients. Participants will be randomized (allocation ratio 1:1): test group (eHealth plus standard of care) versus control group (standard of care only). The primary outcome is oral hygiene as measured by the full mouth (six sites per tooth) plaque control record (PCR) index. The main secondary outcome is gingival inflammation as measured by the full mouth (six sites per tooth) bleeding on probing (BOP) index. Both the primary and the main secondary outcomes are evaluated by blinded and calibrated examiners at 8 weeks of follow up. The other secondary outcomes are patient satisfaction and patient behavior change and motivation. Discussion The study will investigate the value of an innovative eHealth approach to strengthen patient motivation for oral hygiene. If proven effective, such an approach would supplement the current clinical standard of care, resulting in improved clinical outcomes with negligible impact on productivity in a dental practice. Trial registration ClinicalTrials.gov, NCT03109808. Registered on 12 April 2017. Sponsor: Hospices Civils de Lyon. BP 2251, 3 quai des Célestins, 69,229 Lyon cedex 02. Protocol version: 1.0 as of 21 September 2016.

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Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

10.21203/rs.2.475/v2 ◽

2019 ◽

Author(s):

Jian-Feng Tu ◽

Jing-Wen Yang ◽

Li-Qiong Wang ◽

Yang Wang ◽

Jin-ling Li ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Statistical Analysis ◽

Knee Osteoarthritis ◽

Primary Outcome ◽

Controlled Trial ◽

Statistical Analysis Plan ◽

Sham Acupuncture ◽

Manual Acupuncture ◽

Randomized Controlled ◽

Secondary Outcomes

Abstract Background: Acupuncture therapies are widely used for knee osteoarthritis (KOA), despite contradictory evidences. Current study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. Methods/design: Current study is a multi-center, three-arm, randomized controlled trial which will enroll 480 participants with KOA in China. Participants will be randomly assigned (1:1:1) to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8 weeks. The primary outcome is the response rate - the proportion of patients who simultaneously achieve minimal clinically important improvement in pain and function domains at 8 weeks. The primary outcome will be analyzed using Z-test with intention-to-treat set. Secondary outcomes contain pain, function, global patient assessment and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article. The statistical analysis plan was written and submitted without knowledge of the study data. Discussion: The data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and enhance the transparency of current trial. The trial will provide high-quality evidence on the efficacy of acupuncture for KOA.

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Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial

10.21203/rs.3.rs-305564/v1 ◽

2021 ◽

Author(s):

Jing-wen Sun ◽

Zhi-gang Li ◽

Ming-liang Sun ◽

Da Li ◽

Jun Zhao ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Irritable Bowel Syndrome ◽

Social Adjustment ◽

Primary Outcome ◽

Controlled Trial ◽

Randomized Controlled ◽

Self Rating ◽

Multicenter Randomized Controlled Trial ◽

Secondary Outcomes ◽

Irritable Bowel

Abstract Background: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease has been found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients based on conventional treatments. We also want to explore the optimal acupoint combination recommended for IBS and clarify the clinical advantage of "multi-acupoint co-effect and synergistic effect".Methods and analysis: A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly allocated to receive different acupuncture. Each patient will receive 12 acupuncture treatments over four weeks and will be followed up for four weeks. The primary outcome is the IBS-symptom severity score (IBS-SSS). The secondary outcomes include the Bristol stool form scale(BSFS), the work and social adjustment score (WSAS), the IBS-quality of life (IBS-QOL), self-rating anxiety scale (SAS), and the self-rating depression scale (SDS). Both the primary outcome and the secondary outcomes measures are collected at baseline, 2 weeks, and 4 weeks of the intervention, 6 weeks, and 8 weeks after the intervention.Ethics and dissemination: The entire project has been approved by the ethics committee of Beijing University of Chinese Medicine ( 2020BZYLL0903 ) .Discussion: This is a multicenter randomized controlled trial for IBS in China. This may shed light on the efficacy of acupuncture as an alternative to IBS. The results of the trial will be disseminated in peer-reviewed publications. Trial registration: Chinese Clinical Trials Register, ID: ChiCTR2000041215.First registered on 12 December 2020. http://www.chictr.org.cn/.

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LO45: Does the use of point of care ultrasonography improve survival in emergency department patients with undifferentiated hypotension? The first Sonography in Hypotension and Cardiac Arrest in the Emergency Department (SHOC-ED1) Study; an international randomized controlled trial

CJEM ◽

10.1017/cem.2017.107 ◽

2017 ◽

Vol 19 (S1) ◽

pp. S43

Author(s):

P.R. Atkinson ◽

J. Milne ◽

L. Diegelmann ◽

H. Lamprecht ◽

M. Stander ◽

...

Keyword(s):

Emergency Department ◽

Randomized Controlled Trial ◽

Length Of Stay ◽

Diagnostic Accuracy ◽

Standard Care ◽

Primary Outcome ◽

Point Of Care ◽

Controlled Trial ◽

Randomized Controlled ◽

Secondary Outcomes

Introduction: Point of care ultrasound (PoCUS) is an established tool in the initial management of patients with undifferentiated hypotension in the emergency department (ED). While PoCUS protocols have been shown to improve early diagnostic accuracy, there is little published evidence for any mortality benefit. We report the findings from our international multicenter randomized controlled trial, assessing the impact of a PoCUS protocol on survival and key clinical outcomes. Methods: Recruitment occurred at 7 centres in North America (4) and South Africa (3). Scans were performed by PoCUS-trained physicians. Screening at triage identified patients (SBP<100 or shock index>1), randomized to PoCUS or control (standard care and no PoCUS) groups. Demographics, clinical details and study findings were collected prospectively. Initial and secondary diagnoses were recorded at 0 and 60 minutes, with ultrasound performed in the PoCUS group prior to secondary assessment. The primary outcome measure was 30-day/discharge mortality. Secondary outcome measures included diagnostic accuracy, changes in vital signs, acid-base status, and length of stay. Categorical data was analyzed using Fishers test, and continuous data by Student T test and multi-level log-regression testing. (GraphPad/SPSS) Final chart review was blinded to initial impressions and PoCUS findings. Results: 258 patients were enrolled with follow-up fully completed. Baseline comparisons confirmed effective randomization. There was no difference between groups for the primary outcome of mortality; PoCUS 32/129 (24.8%; 95% CI 14.3-35.3%) vs. Control 32/129 (24.8%; 95% CI 14.3-35.3%); RR 1.00 (95% CI 0.869 to 1.15; p=1.00). There were no differences in the secondary outcomes; ICU and total length of stay. Our sample size has a power of 0.80 (α:0.05) for a moderate effect size. Other secondary outcomes are reported separately. Conclusion: This is the first RCT to compare PoCUS to standard care for undifferentiated hypotensive ED patients. We did not find any mortality or length of stay benefits with the use of a PoCUS protocol, though a larger study is required to confirm these findings. While PoCUS may have diagnostic benefits, these may not translate into a survival benefit effect.

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Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial

American Journal of Perinatology ◽

10.1055/s-0040-1708851 ◽

2020 ◽

Author(s):

Melissa S. Wong ◽

Brennan M.R. Spiegel ◽

Kimberly D. Gregory

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Pain Score ◽

Primary Outcome ◽

Controlled Trial ◽

Tertiary Care ◽

Obstetric Outcomes ◽

Care Hospital ◽

Randomized Controlled ◽

Secondary Outcomes

Objective Virtual reality (VR) represents a potential method for easing labor pain and in nonpregnant patients has been shown to achieve similar or greater analgesia than hydromorphone. Few studies of VR have been performed in pregnant women. The aim of this randomized controlled trial (RCT) is to evaluate whether VR is effective in reducing pain in laboring women. Study Design An open-label, RCT of nulliparous, term women in labor in a tertiary care hospital. We included women with a pain score level of 4 to 7 having regular contractions at least every 5 minutes. We excluded women who had received any pharmacologic pain relief including neuraxial analgesia and those with contraindications to VR. Participants were randomized to up to 30 minutes of either VR or the control arm (no additional intervention). Our primary outcome was the difference in differences from pre- to postintervention pain score. Prespecified secondary outcomes included postintervention pain scores, duration of intervention use, pharmacologic analgesia use, maternal vitals, and obstetric outcomes. Results From March 2018 to February 2019, 40 subjects were enrolled, randomized, and completed the study; 19 were randomized to control and 21 to the VR arm. Most baseline characteristics were similar between groups. For the primary outcome, those assigned to the control arm had a statistically significant increase in pain of +0.58, while the VR arm had a significant reduction in pain of −0.52 (p = 0.03). There was also a difference in the proportion who had a minimum clinically important difference in pain (0% control and 23.8% VR; p = 0.049). Postintervention maternal heart rate was higher in the control arm (86.8 vs. 76.3, p = 0.01). Most other secondary outcomes did not differ. Conclusion In our study, we found that VR was effective for reducing pain in women in labor as compared with those receiving no intervention. Key Points

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Feasibility and Subjective Effectiveness Assessment Using a Mobile Health Application for a Health Management Applied Traditional Medicine Perspective: A Randomized Controlled Trial (Preprint)

10.2196/preprints.27455 ◽

2021 ◽

Author(s):

Younghwa Baek ◽

Kyungsik Jeong ◽

Siwoo Lee ◽

Hoseok Kim ◽

Bok-Nam Seo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Mobile Health ◽

Primary Outcome ◽

Health Management ◽

Controlled Trial ◽

Control Group ◽

Health Promoting Behaviors ◽

Randomized Controlled ◽

Health Promoting ◽

Secondary Outcomes

BACKGROUND Mobile health (mHealth) is a major source of health management systems such as health promotion behavior, chronic disease, and mental illness. Moreover, mHealth, a new model of digital healthcare in need of change due to the COVID-19 pandemic, will increase and demand for use worldwide. Accordingly, interest in health care in everyday life and the importance of mobile health are growing. OBJECTIVE We developed a MibyeongBogam (MBBG) application that evaluates the user’s subhealth status by use of a smartphone and provides a health management method based on that user’s subhealth status for use in everyday life. The primary objective of this study was to compare health status awareness after the use of the MBBG application between the intervention and control groups, and to evaluate the application’s practicality. METHODS This study was a prospective, open-label, parallel group, randomized controlled trial as an intervention for MBBG. The study was conducted at two hospitals in Korea with 150 healthy people in their 30s and 40s, at a 1:1 allocation ratio. Participants visited the hospital three times: pre-intervention, intermediate visit six weeks after intervention, and final visit 12 weeks after intervention. Key endpoints were measured at the first visit before intervention and at 12 weeks after intervention. The primary outcome was the awareness of subhealth status and secondary outcomes were health status, health-promoting behaviors, and motivation for healthy behaviors. RESULTS The primary outcome, subhealth awareness, tended to slightly increase in both groups after the uncompensated intervention, but there was no significant difference between groups (MBBG group = 23.69±0.25, control group = 23.1±0.25, p=0.088). In the case of secondary outcomes, only some variables of subhealth status showed significant differences between the two groups after intervention, and the intervention group showed an improvement in the total score of subhealth (p = 0.025), sleep disturbance (p = 0.024), depression (p = 0.003), anger (p = 0.01), and anxiety symptoms (p = 0.009) compared to the control group. CONCLUSIONS In this study, the MBBG application showed positive potential for improving the health, especially the mental health, of individuals without particular health problems. However, the effects of the application on health-promoting behaviors were not clearly evaluated. Therefore, further studies to assess improvements in health after the use of personalized health management programs provided by the MBBG application would need to be performed. It is thought that the MBBG application would be useful for the general public, who are not diagnosed with a disease but cannot enjoy an optimal daily life due to discomfort, to seek strategies that can improve their health. CLINICALTRIAL Clinical Research Information Service, KCT0003488. (https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14379)

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