A Randomized Waitlist-Controlled Trial of an Intergenerational Arts and Heritage-Based Intervention in Singapore: Project ARTISAN

Loneliness has become a global major public health concern, with detrimental effects to the young and old. ARTISAN (Aspiration and Resilience Through Intergenerational Storytelling and Art-based Narratives) is a 5-week, 15-h participatory art and group-based intervention that focuses on resilience building and loneliness alleviation among the young and old through a structured multimodal framework held at a museum space. Developed with a Participatory Action Research (PAR) approach, this intervention is evaluated using an open-label waitlist randomized controlled trial design (RCT) comprised of community-dwelling youth and older adults randomized into an intervention group (n = 35) or a waitlist-control group (n = 33). Participants were assessed on standardized self-reported psychometric measures including loneliness, resilience, quality of life, social support, life satisfaction and national identity at three time points. Qualitative data generated during each intervention session as well as acceptability focus groups were recorded and transcribed. Linear mixed modeling analyses revealed that participants in the intervention group experienced improvements in life satisfaction compared to participants in the waitlist-control group (95% CI: 0.22 to 0.77, p < 0.001, Cohen's d = 0.53) immediately after the completion of ARTISAN. Subgroup analyses for youth participants indicated improvements in quality of life (95% CI: 0.16 to 0.52, p < 0.001, d = 1.31) and national identity (95% CI: 0.18 to 0.80, p = 0.002, d = 0.43) in comparison to the waitlist-control group. At 5-weeks follow-up, the intervention group participants continued to experience high levels of life satisfaction (95% CI: 0.04 to 0.42, p = 0.017, d = 0.47), enhancements in resilience (95% CI: 0.07 to 0.55, p = 0.011, d = 0.46), as well as a significant reduction in loneliness (95% CI: −0.34 to −0.08, p = 0.001, d = 0.61) compared to baseline, reflecting the effectiveness and positive residual effects of the ARTISAN intervention. Similarly, the qualitative findings provided support for the intervention and additional insights to the quantitative findings. This holistic intervention framework that integrates stories, arts and heritage for bridging and empowering lives fills a critical gap in knowledge and practice between the arts, health and citizenship, paving the way for further research in creating a more caring and inclusive society with the arts.Clinical Trials Registration:www.ClinicalTrials.gov, identifier: NCT03048708.

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Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial

Trials ◽

10.1186/s13063-021-05078-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Sai Ho Sin ◽

Jing Wu ◽

Yuchen Kang ◽

Kar Hung Kevin Yip ◽

Ngo Suet Kong ◽

...

Keyword(s):

Quality Of Life ◽

Distress Syndrome ◽

Controlled Trial ◽

Control Group ◽

Waitlist Control ◽

Link Type ◽

Waitlist Control Group ◽

Banxia Xiexin Decoction

Abstract Background Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally regarded as the Wei-Pi syndrome, and Banxia Xiexin decoction (BXD) has been used in the empirical treatment of the same for a long time. The current study aims to evaluate the efficacy of modified BXD in the management of Wei-Pi syndrome. Methods/design A randomized, waitlist-controlled trial will be conducted. A total of 84 patients with Wei-Pi syndrome will be randomized into the BXD or waitlist control group in a ratio of 1:1. The patients in the BXD group will receive the semi-individualized BXD on the basis of the syndrome differentiation in CM, for a duration of 3 weeks and will be under follow-up for further 3 weeks after the completion of therapy. Conversely, the patients in the waitlist control group will undergo the same intervention and follow-up after a 3-week waiting period. In the current study, the primary outcome will be the variation in the scores pertaining to the global scale of the Quality of Life Questionnaire for Functional Digestive Disorders after 3 weeks. The secondary outcomes include the variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests. Discussion This trial will assess the efficacy of modified BXD in improving the clinical symptoms and quality of life of the patients suffering from Wei-Pi syndrome. Trial registration ClinicalTrials.govNCT04398888. Registered on May 21, 2020

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Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

Canadian Respiratory Journal ◽

10.1155/2002/106262 ◽

2002 ◽

Vol 9 (4) ◽

pp. 253-259 ◽

Cited By ~ 21

Author(s):

Robert L Cowie ◽

Margot F Underwood ◽

Cinde B Little ◽

Ian Mitchell ◽

Sheldon Spier ◽

...

Keyword(s):

Quality Of Life ◽

Emergency Department ◽

Randomized Controlled Trial ◽

Asthma Control ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Disease Specific

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

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Impact of a 12-month web and smartphone-based intervention initiated during spa therapy to improve long-term physical activity of patients with chronic diseases: randomized controlled trial. (Preprint)

10.2196/preprints.29640 ◽

2021 ◽

Author(s):

Florie FILLOL ◽

Ludivine PARIS ◽

Sébastien PASCAL ◽

Aurélien MULLIEZ ◽

Christian-François ROQUES ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Waist Circumference ◽

Controlled Trial ◽

Intervention Group ◽

Group Versus ◽

Control Group ◽

Spa Therapy

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.

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Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽

10.1093/qjmed/hcab115.005 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Hatem Hussein El-Gamal ◽

Walid El-Basuony Mohammad ◽

Ahmed Samir Mohamed Zeerban

Keyword(s):

Quality Of Life ◽

Caesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Expectant Management ◽

Control Group ◽

Randomised Controlled ◽

Caesarean Scar Defect ◽

Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

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Impacting Quality of Life for Patients With Advanced Cancer With a Structured Multidisciplinary Intervention: A Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2006.06.209 ◽

2006 ◽

Vol 24 (4) ◽

pp. 635-642 ◽

Cited By ~ 227

Author(s):

Teresa A. Rummans ◽

Matthew M. Clark ◽

Jeff A. Sloan ◽

Marlene H. Frost ◽

John Michael Bostwick ◽

...

Keyword(s):

Quality Of Life ◽

Radiation Therapy ◽

Advanced Cancer ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Analog Scale ◽

Multidisciplinary Intervention ◽

Linear Analog

Purpose The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer. Patients and Methods Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4 (end of multidisciplinary intervention), week 8, and week 27. Results Of the 103 participants, overall QOL at week 4 was maintained by the patients in the intervention (n = 49), whereas QOL at week 4 significantly decreased for patients in the control group (n = 54). This change reflected a 3-point increase from baseline in the intervention group and a 9-point decrease from baseline in the control group (P = .009). Intervention participants maintained their QOL, and controls gradually returned to baseline by the end of the 6-month follow-up period. Conclusion Although intervention participants maintained and actually improved their QOL during radiation therapy, control participants experienced a significant decrease in their QOL. Thus, a structured multidisciplinary intervention can help maintain or even improve QOL in patients with advanced cancer who are undergoing cancer treatment.

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Effects of a Training Intervention for Enhancing Recovery after Ivor-Lewis Esophagus Surgery: A Randomized Controlled Trial

Scandinavian Journal of Surgery ◽

10.1177/1457496916655499 ◽

2016 ◽

Vol 106 (2) ◽

pp. 116-125 ◽

Cited By ~ 1

Author(s):

M. Fagevik Olsén ◽

G. Kjellby Wendt ◽

E. Hammerlid ◽

U. Smedh

Keyword(s):

Quality Of Life ◽

Lung Function ◽

Range Of Motion ◽

Physical Function ◽

Controlled Trial ◽

Intervention Group ◽

Training Intervention ◽

Control Group ◽

Ivor Lewis

Background and Aims: There is a risk of decreased physical function, quality of life and persistent pain after open surgery for esophageal cancer. There are currently no studies that evaluate the effect of any postoperative intervention, including physical exercises, after this type of surgery. The aim of the study was therefore to evaluate the effect of a training intervention after Ivor-Lewis resection of the esophagus. Material and Methods: Patients scheduled for esophagus resection according to Ivor-Lewis were randomized to an intervention group or a control group. The training intervention started at discharge and lasted three months. Before discharge, patients were given three leaflets with exercises to increase range of motion in the affected area and exercises aiming to restore lung function and physical function. All exercises were described in detail and the patients carried out the ones in the first program under supervision. Before surgery and three months after discharge, the patients estimated their level of physical function, level of physical activity, and quality of life. They also underwent spirometry, measurements of range of motion in the rib cage, spine, and shoulders, and three functional tests. Comparisons of differences within and between the groups were made. Results: A total of 43 of 64 randomized patients participated in the follow-up. Postoperatively, the patients in the intervention group had a significantly higher degree of physical function and less deteriorated range of motion in right shoulder flexion and thoracic left lateral flexion. There were no significant differences between the groups in lung function, pain, or quality of life. Conclusion: The results of the three-month intervention indicate that specific training can positively affect physical function and range of motion to preoperative values. The intervention was well tolerated, and no side effects were registered.

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AwareCare: a pilot randomized controlled trial of an awareness-based staff training intervention to improve quality of life for residents with severe dementia in long-term care settings

International Psychogeriatrics ◽

10.1017/s1041610212001226 ◽

2012 ◽

Vol 25 (1) ◽

pp. 128-139 ◽

Cited By ~ 34

Author(s):

Linda Clare ◽

Rhiannon Whitaker ◽

Robert T Woods ◽

Catherine Quinn ◽

Hannah Jelley ◽

...

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Care Home ◽

Intervention Group ◽

Well Being ◽

Care Staff ◽

Control Group ◽

Severe Dementia ◽

Term Care

ABSTRACTBackground: The extent to which care home residents with severe dementia show awareness is influenced by the extent to which the environment provides opportunities for engagement and by the way in which care staff interact with them. We aimed to establish whether training care staff to observe and identify signs of awareness in residents with severe dementia resulted in improved quality of life for residents.Methods: In this pilot cluster randomized trial, care staff in four homes (n = 32) received training and supervision and carried out structured observations of residents using the AwareCare measure (n = 32) over an eight-week period, while staff in four control homes (n = 33) had no training with regard to their residents (n = 33) and no contact with the research team. The primary outcome was resident quality of life. Secondary outcomes were resident well-being, behavior and cognition, staff attitudes and well-being, and care practices in the home.Results: Following intervention, residents in the intervention group had significantly better quality of life as rated by family members than those in the control group, but care staff ratings of quality of life did not differ. There were no other significant between-group differences. Staff participating in the intervention identified benefits in terms of their understanding of residents’ needs.Conclusions: Staff were able to use the observational measure effectively and relatives of residents in the intervention homes perceived an improvement in their quality of life.

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Mindful gratitude journaling: psychological distress, quality of life and suffering in advanced cancer: a randomised controlled trial

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2021-003068 ◽

2021 ◽

pp. bmjspcare-2021-003068

Author(s):

Ting Ting Tan ◽

Maw Pin Tan ◽

Chee Loong Lam ◽

Ee Chin Loh ◽

David Paul Capelle ◽

...

Keyword(s):

Quality Of Life ◽

Psychological Distress ◽

Randomised Controlled Trial ◽

Advanced Cancer ◽

Controlled Trial ◽

Intervention Group ◽

Mean Difference ◽

Control Group ◽

Randomised Controlled

ContextNumerous studies have shown that gratitude can reduce stress and improve quality of life.ObjectiveOur study aimed to examine the effect of mindful gratitude journaling on suffering, psychological distress and quality of life of patients with advanced cancer.MethodsWe conducted a parallel-group, blinded, randomised controlled trial at the University of Malaya Medical Centre, Malaysia. Ninety-two adult patients with advanced cancer, and an overall suffering score ≥4/10 based on the Suffering Pictogram were recruited and randomly assigned to either a mindful gratitude journaling group (N=49) or a routine journaling group (N=43).ResultsAfter 1 week, there were significant reductions in the overall suffering score from the baseline in both the intervention group (mean difference in overall suffering score=−2.0, 95% CI=−2.7 to −1.4, t=−6.125, p=0.000) and the control group (mean difference in overall suffering score=−1.6, 95% CI=−2.3 to −0.8, t=−4.106, p=0.037). There were also significant improvements in the total Hospital Anxiety and Depression Scale score (mean difference=−3.4, 95% CI=−5.3 to −1.5, t=−3.525, p=0.000) and the total Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being score (mean difference=7.3, 95% CI=1.5 to 13.1, t=2.460, p=0.014) in the intervention group after 7 days, but not in the control group.ConclusionThe results provide evidence that 7 days of mindful gratitude journaling could positively affect the state of suffering, psychological distress and quality of life of patients with advanced cancer.Trial registration numberThe trial was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1261800172191) and conducted in accordance with the Declaration of Helsinki.

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Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽

10.2196/20747 ◽

2020 ◽

Vol 3 (1) ◽

pp. e20747

Author(s):

Mahboube Davoudi ◽

Tahereh Najafi Ghezeljeh ◽

Farveh Vakilian Aghouee

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Clinical Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

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Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.30191 ◽

2021 ◽

Author(s):

Mohammad Habibur Rahman Sarker ◽

Michiko Moriyama ◽

Harun Ur Rashid ◽

Md Moshiur Rahman ◽

Mohammod Jobayer Chisti ◽

...

Keyword(s):

Quality Of Life ◽

Chronic Kidney Disease ◽

Randomized Controlled Trial ◽

Kidney Disease ◽

Health Education ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled

BACKGROUND Despite the growing burden of chronic kidney disease (CKD), disease knowledge and understanding are still lacking, especially in Bangladesh. OBJECTIVE The aim of this study was to evaluate the outcome of a health education intervention in order to enhance knowledge, health-related quality of life (QOL), and motivation regarding healthy lifestyles among rural and periurban adults suffering from CKD. METHODS A parallel-group (1:1) randomized controlled trial is ongoing in the Mirzapur subdistrict, Bangladesh, where two groups of patients with CKD are being compared. Patients aged 18 years and over with CKD (stages 1-3) were enrolled in November 2020. Patients were randomly allocated into either the intervention group (n=63) or the control group (n=63). The control group received usual treatment, while the intervention group received health education through a CKD campaign facilitated by a nephrologist and via mHealth (ie, periodic mobile phone calls) from community health workers. Both groups were followed up for a period of 6 months. The primary endpoint is patients’ increased knowledge measured using the Chronic Kidney Disease Knowledge Questionnaire. The secondary endpoints are improved QOL measured using the standardized EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire as well as improvements in the levels of blood pressure, BMI, serum creatinine, fasting blood sugar, hemoglobin, cholesterol, high-density lipoprotein cholesterol, triglyceride, serum uric acid, blood urea nitrogen, and albumin to creatinine ratio. RESULTS Enrollment of participants began in November 2020; the intervention and follow-up were completed in May 2021. We enrolled 126 patients in the study. Patients’ mean ages were 57.97 (SD 15.03) years in the control group and 57.32 (SD 14.37) years in the intervention group. There were 45 out of 63 (71%) females in the control group and 38 out of 63 (60%) females in the intervention group. In addition, there were 38 out of 63 (60%) literate patients in the control group and 33 out of 63 (52%) literate patients in the intervention group. CONCLUSIONS It is expected that a combined approach, incorporating both a CKD campaign and mHealth, for health education may be an effective tool for increasing knowledge and improving QOL among patients with CKD. CLINICALTRIAL ClinicalTrials.gov NCT04094831; https://clinicaltrials.gov/ct2/show/NCT04094831 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30191

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