scholarly journals Electroacupuncture for treatment-resistant insomnia: study protocol for a randomised, controlled, assessor-blinded, pilot clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034239
Author(s):  
Jung-Hwa Lim ◽  
Kyung-Ok Kim ◽  
Sang-Ho Kim ◽  
Chang-Wan Kang ◽  
Bo-Kyung Kim
Keyword(s):  
Pilot Study ◽  
Sleep Quality ◽  
Usual Care ◽  
Study Protocol ◽  
Usual Care Group ◽  
Sleep Diary ◽  
Secondary Outcome ◽  
Care Group ◽  
Treatment Resistant ◽  
Hypnotic Medication

IntroductionA considerable number of insomnia patients experience sleep disturbance even with long-term use of hypnotic medication. Previous studies have indicated that electroacupuncture (EA) could be an efficacious treatment for managing insomnia. However, few trials have been conducted to evaluate the effectiveness and safety of EA for treatment-resistant insomnia. This pilot study aims to explore the feasibility and preliminary effectiveness and safety of EA as an adjunct treatment for treatment-resistant insomnia.Methods and analysisThis is a multicentre, randomised, usual care controlled and assessor-blinded pilot study protocol. Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months will be randomly allocated to either an EA group or a usual care group at a 1:1 ratio. The EA group will undergo 12 EA treatment sessions twice a week for 6 weeks whereas the usual care group will not receive EA treatment. All the participants will receive a brochure containing educational information on sleep hygiene. The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7. The secondary outcome regarding sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Moreover, we will assess the quality of life, the direct and indirect cost of treating insomnia for economic evaluation. After 4 weeks, the subjects will visit the research sites for a follow-up assessment.Ethics and disseminationEthical approval of this study protocol was established by the institutional review boards of the each involved study site. All potential subjects will be provided written informed consent. The results of this study will be accessible in peer-reviewed publications and be presented at academic conference.Trial registration numberKCT0003235.

scholarly journals Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016269 ◽  
Author(s):  
Mikyung Kim ◽  
Jung-Eun Kim ◽  
Hye-Yoon Lee ◽  
Ae-Ran Kim ◽  
Hyo-Ju Park ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Usual Care ◽  
Study Protocol ◽  
Usual Care Group ◽  
Sleep Diary ◽  
Research Centre ◽  
Care Group ◽  
Patients With Cancer ◽  
Patient Reported

IntroductionAlthough insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep.Methods and analysisThis is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment.Ethics and disseminationThis study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences.Trial registration numberKCT0002162; Pre-results.

scholarly journals Behavioral-educational sleep interventions for pediatric epilepsy: a randomized controlled trial

SLEEP ◽  
2019 ◽  
Vol 43 (1) ◽  
Author(s):  
Shao-Yu Tsai ◽  
Wang-Tso Lee ◽  
Chien-Chang Lee ◽  
Suh-Fang Jeng ◽  
Wen-Chin Weng
Keyword(s):  
Sleep Quality ◽  
Usual Care ◽  
Usual Care Group ◽  
Preschool Age ◽  
Care Group ◽  
Pediatric Epilepsy ◽  
Maternal Knowledge ◽  
Sleep Habits ◽  
Intervention Effects ◽  
Maternal Sleep

Abstract Study Objectives To evaluate the effect of a clinic-based, behavioral-educational sleep intervention on sleep of children with epilepsy, maternal knowledge about childhood sleep, and maternal sleep quality. Methods A total of 100 toddlers and preschool-age children with epilepsy (1.5–6 years, 55% boys) and their parents were randomized to receive sleep intervention (n = 50) or usual care with attention (n = 50). Outcomes were assessed at baseline, 3, 6, and 12 months after intervention with the use of objective actigraphy, Children’s Sleep Habits Questionnaire, Parents’ Sleep Knowledge Inventory, and Pittsburgh Sleep Quality Index. Intervention effects were examined using general linear models for repeated measurements to compare the mean change in outcomes from baseline to 12 months post-intervention between the two groups. Results Sleep intervention resulted in children having greater sleep efficiency by 2.03% compared with the usual care group (95% CI = 0.20% to 3.86%; p = .03). Children in the intervention group also had significantly longer total nighttime sleep as objectively assessed by actigraphy than did those in the usual care group, with an adjusted mean difference of 16.13 minutes (95% CI = 0.24% to 32.03%; p = .04). No intervention effects were observed for maternal knowledge about childhood sleep, and maternal sleep quality. Conclusion Sleep intervention provided during routine neurologic visits results in significant, measurable, and sustained benefits in sleep quality and quantity in children with epilepsy. Future trials are warranted to evaluate whether improvements in sleep could impact health-related quality of life or other aspects of functioning in children with epilepsy. Clinical Trial This trial has been registered at www.clinicaltrials.gov (trial name: Sleep Intervention for Pediatric Epilepsy; registration number: NCT02514291).

FRI0512 INTEGRATED CARE NETWORK AS A BUILDING STONE FOR SUSTAINABLE AND COMPREHENSIVE CARE FOR PATIENTS WITH ARTHRALGIA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 855.1-855
Author(s):  
E. Van Delft ◽  
K. H. Han ◽  
J. Hazes ◽  
D. Lopes Barreto ◽  
A. Weel
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
Integrated Care ◽  
Usual Care Group ◽  
Inflammatory Arthritis ◽  
Care Setting ◽  
Primary Care Setting ◽  
Care Group ◽  
Care Network ◽  
The Right

Background:Western countries experience an increasing demand for care, particularly for inflammatory arthritis (IA), while the healthcare budget decreases1. The innovative value-based primary care strategy2includes integrated care networks, where primary and secondary care bundle their expertise to improve patient value by providing the right care at the right place.General practitioners (GPs) have difficulties recognising IA, leading up to only 20% IA diagnoses of all newly referred arthralgia patients. However, since IA needs to be treated as early as possible to overcome progression, it is worthwhile to analyse whether integrated care networks have an impact on patient outcomes and cost-effectiveness. Triage by a rheumatologist in a primary care setting is one of the most promising integrated care networks for efficient referrals3.Objectives:To assess the effect of triage by a rheumatologist in a primary care setting in patients suspect for inflammatory arthritis.Methods:The present study follows a cluster randomized controlled trial design. The intervention, triage by a rheumatologist in a local primary care centre, will be compared to usual care. Usual care means that patients are referred to a rheumatology outpatient clinic based on the opinion of the general practitioner.The primary outcome is the frequency of IA diagnoses assessed by a rheumatologist. Patient reported outcome measures (PROMs (EQ-5D)) and costs (work productivity (iPCQ) and healthcare utilization (iMCQ)) were determined at baseline, after three, six and twelve months. The target was to include 267 patients for each study group (power level 0.8). Since this study is still ongoing we can only show first results on the efficiency of referrals.Results:In the period between February 2017 and December 2019 a total of 543 participants were included; 275 in the usual care group and 268 in the triage group. Mean age (51.3 ± 14.6 years) and percentage of men (23.6%) were comparable between groups (page=0.139; psex=0.330).The preliminary data show that the number of referred patients in the triage group is n=28 (10.5%) (Fig. 1). 32 patients (11.9%) were not referred directly but advice was given for additional diagnostics. Since all patients in the usual care group were referred there is a decrease of at least 77.6% in referrals when rheumatologists are participating in the integrated practice units.Preliminary data on diagnosis are available for all referred patients in the triage group and for n=137 (49.8%) in the usual care group at this point. In the triage group n=18 (64.2%) of referred patients were diagnosed with IA (6.7% of the total study population). In the usual care group this was n=52 (38.0%) of the patients yet diagnosed.Conclusion:These preliminary results of an integrated care network are promising. Approximately three-quarters of all patients can be withheld from expensive outpatient care. PROMs data and cost-effectiveness analysis will give clear answers in order to provide evidence whether this integrated care network can be implemented as a standard of care.References:[1] Rijksoverheid. (2018). Bestuurlijk akkoord medisch-specialistische zorg 2019 t/m 2022.https://www.rijksoverheid.nl/.[2] Porter ME, Pabo EA, Lee TH. (2013). Redesigning Primary Care: a strategic vision to improve value by organizing around patients’ needs. Health affairs, 32(3);516-525[3] Akbari A, et al. (2008). Interventions to improve outpatient referrals from primary care to secondary care. Cochrane Database Syst Rev, 4,CD005471.Disclosure of Interests:None declared

scholarly journals Effect of Early Rehabilitation on Physical Function in Patients Undergoing Coronary Artery Bypass Grafting: A Nationwide Inpatient Database Study

2021 ◽  
Vol 10 (4) ◽  
pp. 618
Author(s):  
Hiroyuki Ohbe ◽  
Kensuke Nakamura ◽  
Kazuaki Uda ◽  
Hiroki Matsui ◽  
Hideo Yasunaga
Keyword(s):  
Coronary Artery ◽  
Coronary Artery Bypass Grafting ◽  
Usual Care ◽  
Physical Function ◽  
Usual Care Group ◽  
Artery Bypass ◽  
Early Rehabilitation ◽  
Care Group ◽  
Bypass Grafting ◽  
Inpatient Database

It is unclear when to begin rehabilitation after coronary artery bypass grafting (CABG) in the intensive care unit (ICU). Using the Japanese Diagnosis Procedure Combination inpatient database from 2010 to 2018, we identified adult patients who underwent a CABG and who were admitted to the ICU for ≥3 consecutive days from the date of their CABG. Patients who started any rehabilitation program prescribed by physicians or therapists within 3 days of CABG were defined as the early rehabilitation group, and the remaining patients were defined as the usual care group. We identified 30,568 eligible patients, with 13,150 (43%) patients in the early rehabilitation group. An inverse probability of treatment weighting analyses showed that the Barthel Index score at discharge in the early rehabilitation group was significantly higher than that in the usual care group (difference: 3.2; 95% confidence interval: 1.5–4.8). The early rehabilitation group had significantly lower in-hospital mortality, total hospitalization costs, length of ICU stay, and hospital stay vs. the usual care group. Our results suggested that early rehabilitation by physicians or therapists beginning within 3 days of CABG was safe, as suggested by the low mortality and improved physical function in patients who underwent CABG.

scholarly journals Rice farming care as a novel method of green care farm in East Asian context: an implementation research

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chiaki Ura ◽  
Tsuyoshi Okamura ◽  
Sachiko Yamazaki ◽  
Masaya Shimmei ◽  
Keisuke Torishima ◽  
...  
Keyword(s):  
East Asia ◽  
Usual Care ◽  
Usual Care Group ◽  
Well Being ◽  
Care Group ◽  
Rice Farming ◽  
People With Dementia ◽  
Significant Difference ◽  
Positive Experiences ◽  
Green Care Farms

Abstract Background Green care farms, which offer care for people with dementia in a farm setting, have been emerging in the Netherlands. The aim of this study was to 1) implement green care farms which use rice farming in Japan, 2) explore the positive experiences of rice farming care, and 3) compare the effect of rice farming care to that of usual care on well-being and cognitive ability. Methods We developed a new method of green care farm in Japan which uses rice farming, a farming that is practiced all over East Asia. The participants were 15 people with dementia (mean age = 75.6 ± 9.8 years) who participated in a one-hour rice farming care program once a week for 25 weeks. We also collected qualitative data on the positive experiences of study participants after the program. As a reference data, we also collected the corresponding data of the usual care group which included 14 people with dementia (mean age = 79.9 ± 5.8 years) who were attending the near-by day-care. Results The mean participation rate on the rice farming care group was 72.1%. After the intervention, participants reported experiencing enjoyment and connection during the program. It also changed the staff’s view on dementia. The green care farm group showed a significant improvement in well-being but no significant difference in cognitive function compared to the usual care group. Conclusions Green care farms by using rice farming is promising care method which is evidence-based, empowerment-oriented, strengths-based, community-based dementia service, which also delivers meaningful experience for the people with dementia in East Asia. Trial registration UMIN, UMIN000025020, Registered 1 April 2017.

scholarly journals Randomised controlled study of two counselling models at the Swedish alcohol helpline: Effectiveness and sustainability outcomes at 12-month follow-up

2021 ◽  
pp. 145507252110078
Author(s):  
Thi-Thuy-Dung Nguyen ◽  
Eleonor Säfsten ◽  
Filip Andersson ◽  
Maria Rosaria Galanti
Keyword(s):  
Alcohol Use ◽  
Usual Care ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Risk Level ◽  
Care Group ◽  
Structured Intervention ◽  
Randomised Controlled ◽  
Level Reduction

Aim: This two-arm parallel randomised controlled trial explored the effectiveness of a brief counselling model compared with the usual multi-session counselling at an alcohol telephone helpline. Methods: A total of 320 callers who contacted the Swedish Alcohol Helpline (SAH) because of hazardous or harmful alcohol use were randomised to either brief structured intervention (self-help booklet plus one proactive call) or usual care (multi-session telephone counselling). The primary outcome was a downward shift in risk level at 12-month follow-up compared with baseline, based on self-reports. Sustained risk level reduction throughout the whole follow-up was also assessed as secondary outcome. Results: Both interventions were significantly associated with a shift to a lower level of risky alcohol use (75% among participants in the brief structured intervention, and 70% in the usual care group) after 12 months. There was no difference between the two interventions in the proportions changing alcohol use or sustaining risk level reduction. Conclusion: In the context of telephone helplines, minimal and extended interventions appear to be equally effective in promoting long-term change in alcohol use.

The effect of a mobile health app on adherence to physical health treatment. (Preprint)

2021 ◽  
Author(s):  
Jay Greenstein ◽  
Robert Topp ◽  
Jena Etnoyer-Slaski ◽  
Michael Staelgraeve ◽  
John McNulty ◽  
...  
Keyword(s):  
Physical Health ◽  
Mobile Phone ◽  
Usual Care ◽  
Usual Care Group ◽  
Clinic Visit ◽  
Care Group ◽  
Health Treatment ◽  
Rehabilitation Clinic ◽  
The Impact ◽  
Clinic Visits

BACKGROUND Adhering to prescribed medical interventions predicts the efficacy of the treatment. In the physical health clinics, not adhering to prescribed therapy can take the form of not attending a scheduled clinic visit (no-show appointment) or prematurely terminating treatment against the advice of the provider (self-discharge). A variety of interventions, including mobile phone apps have been introduced with patients to increase their adherence with attending scheduled clinic visits. Limited research has examined the impact of a mobile phone app among patients attending a chiropractic and rehabilitation clinic visits. OBJECTIVE The purpose of this study was to compare adherence with prescribed physical health treatment among patients attending a chiropractic and rehabilitation clinic who did and did not choose to adopt a phone-based app to complement their treatment. METHODS The medical records of new patients who presented for care during 2019 and 2020 at five community-based chiropractic and rehabilitation clinics were reviewed for the number of kept and no-show appointments and if the patient was provider discharged or self-discharged. During this 24-month study 36.3% of the 4,126 patients seen in the targeted clinics had downloaded the Kanvas App to their mobile phone while the remaining patients chose not to download the app (Usual Care Group). The gamification component of the Kanvas app provided the patient with a point every time they attended their visits which could be redeemed for an incentive. RESULTS During both 2019 and 2020 respectively the Kanvas App Group (50%-38%) were provider discharged at a greater rate than the Usual-Care group (47-31%). The Kanvas App Group kept a similar number of appointments compared to the Usual-Care Group in 2019 (10.20 vs. 8.68) but kept significantly more appointments than the Usual-Care Group in 2020 (11.63 vs. 7.67). During 2019 both groups exhibited a similar number of no-show appointments (1.89 vs 1.96) but in 2020 the Kanvas App Group demonstrated more no-show appointments (2.89 vs 2.14) than the Usual Care. When collapsed across years and self discharged the Kanvas App group had a greater number of kept appointments (7.79) compared to the Usual Care group (4.58). When provider discharged both groups exhibited a similar number of kept appointments (15.25 vs 13.82). The Kanvas App group (1.38) and the Usual Care group (1.34) were similar in the number of no-show appointments when provider discharged and when self-discharged the Kanvas App Group had more no-show appointments (3.37) compared to the Usual Care Group (2.44). CONCLUSIONS When patients were provider discharged, they exhibited a similar number of kept appointments and no-show appointment. When subjects were self-discharged and received the Kanvas App they exhibited 3.2 more kept appointments and .94 more no-show appointments than self-discharged Usual Care group.

Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

2022 ◽  
Author(s):  
Maryam Zahid ◽  
Ume Sughra
Keyword(s):  
Nutritional Status ◽  
Usual Care ◽  
Usual Care Group ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
Randomized Controlled ◽  
Nutritional Status Of Children ◽  
Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

Critical illness myopathy in intensive care setting

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Mostafa K Fouad ◽  
Ashraf M Hazem ◽  
Kareem M Elnaghy
Keyword(s):  
Critical Illness ◽  
Mortality Rate ◽  
Usual Care ◽  
Usual Care Group ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Care Group ◽  
Fixed Effects Model ◽  
Analysis Study ◽  
Number Of Patients

Abstract Aim of the Work to provide cumulative data about the efficacy and safety of neuro-muscular electrical stimulation (NMES) combined with usual care (UC) versus usual care alone in ICU patients with Critical Illness Myopathy (CIM). Methodology The current systematic review was done on studies published between 2009 and 2019. The total number of patients in all the included studies was 1259 patients; 652 in NMES group, and 607 in UC group. Our data were divided into two groups: NMES (652 patients), and UC (607 patients). Metaanalysis study was done on 11 studies which described and compared the 2 different techniques for treatment of CIM; with overall number of patients (N = 1259). Results Regarding 1ry outcome measures, we found 8 studies reported critical Critical illness myopathy (CIM), critical illness polyneuropathy (CIP), and the overlap, critical care setting   MRC scale for muscle strength, with total number of patients (N = 968). The random-effects model of the meta-analysis study showed non-significant difference in mean MRC scale in NMES group compared to usual care group (p > 0.05). We also found 11 studies reported ICU stay with total number of patients (N = 1259). The random-effects model of the meta-analysis study showed nonsignificant difference in mean ICU stay in NMES group compared to usual care group (p > 0.05). We also found only 2 studies reported SF-36 scale for quality of life, with total number of patients (N = 270). The fixed-effects model of the metaanalysis study showed highly significant decrease in mean SF-36 scale in NMES group compared to usual care group (p = 0.003). Regarding 2ry outcome measure, we found 3 studies reported CIM incidence with total number of patients (N = 394). The fixed-effects model of the meta-analysis study showed marked decrease in CIM incidence in NMES group compared to usual care group, but not reaching statistical significance (p > 0.05). We also found 9 studies reported mortality rate with total number of patients (N = 1044). The fixed-effects model of the meta-analysis study showed non-significant difference in mortality rate in NMES group compared to usual care. Our systematic review and meta-analysis showed that NMES combined with usual care was not associated with significant differences in global muscle strength, ICU stay, quality of life score, CIM incidence and mortality rate in comparison with usual care alone in critically ill patients. Conclusion NMES is not superior to usual care in management of CIM. Usual care remains the mainstay of management of CIM with significant better outcomes, in addition to preventive measures as early aggressive treatment of sepsis and MOF, blood glucose control, optimizing certain drugs use, early enteral nutrition, maintaining water, electrolyte and acidbase balance.

scholarly journals Cost-Effectiveness Analysis of a Mobile-Based Intervention for Patients with Type 2 Diabetes Mellitus

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Jing Li ◽  
Li Sun ◽  
Yabing Hou ◽  
Liming Chen
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Usual Care ◽  
Usual Care Group ◽  
Management Mode ◽  
Care Group

Objective. The aim of this study was to evaluate the cost effectiveness of a mobile-based intervention for patients with type 2 diabetes mellitus (T2DM) and compare it with the usual management mode. Method. A total of 215 patients with T2DM in a tertiary-care hospital specific to diabetes were selected as the study population. This study was conducted from January 1, 2019 to January 1, 2020. Of the 215 patients, 130 were randomly assigned to the mHealth group and 85 were assigned to the usual care group. IBM SPSS 25.0 software was used for descriptive statistics, t tests, chi-square tests, and correlation analyses. Haemoglobin A1c (HbA1c) was the effectiveness parameter adopted. Cost-effectiveness analyses were performed, and incremental cost-effectiveness ratios (ICERs) were calculated. Results. Of the 215 patients with T2DM, the proportion of male patients was 66.0%. The mean age of the patients was 47.2 (SD 9.95). Differences in baseline information were not statistically significant between the two groups ( P > 0.05 ). At the 3-, 6-, and 12-month follow-ups, the mHealth group reported higher control rates of HbA1c than the usual care group, 67.9% versus 46.2% ( P < 0.001 ), 72.4% versus 45.4% ( P < 0.001 ), and 74.6% versus 47.1% ( P < 0.001 ), respectively. The value of HbA1c was positively related to total patient cost, material fee, Western medicine fee, and hospitalization expenses ( P < 0.05 ), with correlation coefficients of 0.202, 0.200, 0.172, and 0.183, respectively. The costs of the mHealth group and usual care group were CNY¥ 1169.76 and CNY¥ 1775.44 per patient/year, respectively. The incremental cost of the mHealth intervention was CNY¥ −605.68 per patient/year. The ICER was CNY¥ −22.02 per patient/year. Conclusion. Compared with the usual care mode, the mHealth management model for patients with T2DM improved the control rate of HbA1c, and the mHealth management mode had better cost effectiveness.

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