Dataset Information

Randomised controlled trial of a smartphone application-based dietary self-management program on haemodialysis patients.

ABSTRACT:

Aims and objectives

To develop a smartphone application-based dietary self-management program for haemodialysis patients and to examine its effects on biochemical indicators, self-efficacy and quality of life.

Background

Lack of dietary management in haemodialysis patients can lead to serious complications such as oedema, hyponatremia, hyperkalaemia, hypertension, uraemia and eventually death; however, studies using smartphone applications for dietary self-management in haemodialysis patients are rare.

Design

A prospective, single-blind, randomised, controlled design with repeated measures was followed with 75 haemodialysis patients at a haemodialysis centre. Data were collected from 10 January 2017-6 May 2018. The study applied the Consolidated Standards of Reporting Trials statement.

Methods

The 8-week smartphone application-based dietary self-management program was developed through collaboration with a haemodialysis equipment company. The experimental group took this program while the control group took an 8-week general program. Study variables were serum phosphorus, potassium and albumin, self-efficacy and quality of life. They were measured at pretest, and 8 weeks and 12 weeks after the programs, and analysed using two-way repeated measures analysis of variance.

Findings

The smartphone application-based program significantly improved serum phosphorus, potassium, self-efficacy and quality of life over time compared with the general program. There was no significant difference in albumin level changes between the groups.

Conclusions

The smartphone application-based dietary self-management program is an opportune and effective nursing intervention to lower serum phosphorus and potassium levels in haemodialysis patients over time. Trial registration was performed on www.cris.nih.go.kr (KCT0005366).

Relevance to clinical practice

Haemodialysis patients can easily use the smartphone application to manage their diet anytime and anywhere. They can get real-time feedback and solutions to prevent haemodialysis complications. Nurses can provide tailored high-quality care based on an individual's lifelog data from the smartphone application.

SUBMITTER: Pack S

PROVIDER: S-EPMC8048988 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ObjectivesTo test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.DesignA two-arm unblinded feasibility RCT.SettingSix NHS EIP services in England.ParticipantsAdults using EIP services who own an Android Smartphone. Participants were recruited until the recruitment target was met (n=40).InterventionsParticipants were randomised with a 1:1 allocation to one of two conditions: (1) treatment as usual from EIP services (TAU) or (2) TAU plus access to My Journey 3 on their own Smartphone. My Journey 3 features a range of self-management components including access to digital recovery and relapse prevention plans, medication tracking and symptom monitoring. My Journey 3 use was at the users' discretion and was supported by EIP service clinicians. Participants had access for a median of 38.1 weeks.Primary and secondary outcome measuresFeasibility outcomes included recruitment, follow-up rates and intervention engagement. Participant data on mental health outcomes were collected from clinical records and from research assessments at baseline, 4 months and 12 months.Results83% and 75% of participants were retained in the trial at the 4-month and 12-month assessments. All treatment group participants had access to My Journey 3 during the trial, but technical difficulties caused delays in ensuring timely access to the intervention. The median number of My Journey 3 uses was 16.5 (IQR 8.5 to 23) and median total minutes spent using My Journey 3 was 26.8 (IQR 18.3 to 57.3). No serious adverse events were reported.ConclusionsRecruitment and retention were feasible. Within a trial context, My Journey 3 could be successfully delivered to adults using EIP services, but with relatively low usage rates. Further evaluation of the intervention in a larger trial may be warranted, but should include attention to implementation.Trial registrationISRCTN10004994.

Project description:Evaluating and comparing the effectiveness of two smartphone-delivered treatments: one based on behavioural activation (BA) and other on mindfulness.Parallel randomised controlled, open, trial. Participants were allocated using an online randomisation tool, handled by an independent person who was separate from the staff conducting the study.General community, with recruitment nationally through mass media and advertisements.40 participants diagnosed with major depressive disorder received a BA treatment, and 41 participants received a mindfulness treatment. 9 participants were lost at the post-treatment.An 8-week long behaviour programme administered via a smartphone application. Mindfulness: An 8-week long mindfulness programme, administered via a smartphone application.The Beck Depression Inventory-II (BDI-II) and the nine-item Patient Health Questionnaire Depression Scale (PHQ-9).81 participants were randomised (mean age 36.0 years (SD=10.8)) and analysed. Results showed no significant interaction effects of group and time on any of the outcome measures either from pretreatment to post-treatment or from pretreatment to the 6-month follow-up. Subgroup analyses showed that the BA treatment was more effective than the mindfulness treatment among participants with higher initial severity of depression from pretreatment to the 6-month follow-up (PHQ-9: F (1, 362.1)=5.2, p<0.05). In contrast, the mindfulness treatment worked better than the BA treatment among participants with lower initial severity from pretreatment to the 6-month follow-up (PHQ-9: F (1, 69.3)=7.7, p<0.01); BDI-II: (F(1, 53.60)=6.25, p<0.05).The two interventions did not differ significantly from one another. For participants with higher severity of depression, the treatment based on BA was superior to the treatment based on mindfulness. For participants with lower initial severity, the treatment based on mindfulness worked significantly better than the treatment based on BA.Clinical Trials NCT01463020.

Project description:IntroductionMental health interventions delivered through digital technology have potential applications in promoting recovery and improving outcomes among people in the early stages of psychosis. Self-management approaches are recommended for the treatment of psychosis and could be delivered via applications (apps) installed on Smartphones to provide low-cost accessible support. We describe the protocol for a feasibility trial investigating a self-management Smartphone app intervention for adults using Early Intervention in Psychosis (EIP) services.Methods and analysisIn this feasibility randomised controlled trial, 40 participants will be recruited from EIP services in London and Surrey. Twenty participants will be randomised to receive a supported self-management Smartphone app (My Journey 3) plus Treatment As Usual (TAU), while the other 20 participants will receive TAU only. The primary objective of this study is to evaluate the feasibility of conducting a full-scale trial of this intervention in EIP services. Participant data will be collected at baseline and at two follow-up assessments conducted 4 months and 12 months post-baseline. Analysed outcome measures will include relapse of psychosis (operationalised as admission to a hospital or community acute alternative), mental health and well-being, recovery, quality of life and psychopathology. Semi-structured interviews with participants and EIP service clinicians will additionally explore experiences of using My Journey 3 and participating in the trial and suggestions for improving the intervention.Ethics and disseminationThe App to support Recovery in Early Intervention Services study has been reviewed and approved by the National Research Ethics Service Committee London-Brent (Research Ethics Committee reference: 15/LO/1453). The findings of this study will be disseminated through peer-reviewed scientific journals and conferences, magazines and web publications.Trial registration numberISRCTN10004994.

Project description:BackgroundHealth care providers aim to stimulate self-management in type 2 diabetes (T2DM) patients. However, they have a limited number of patient contacts to do this. With the growing number of T2DM patients, innovative and cost-effective interventions to promote self-management are needed. We aim to evaluate the effectiveness of diabetes self-management education via a smartphone app in T2DM patients on insulin therapy.MethodsNon-blinded two-arm multi-centre randomised controlled superiority trial with parallel-groups and equal randomisation ('TRIGGER study'). Eligible patients are 40-70 years, on insulin therapy since at least 3 months, with HbA1c > 53 mmol/mol (> 7%). In total 228 patients will be recruited. The intervention group (n = 114) will receive diabetes self-management education via a smartphone app to trigger diabetes self-management: unidirectional text messages, free of charge, evidence and psychological theory based, with regard to dietary habits, physical activity, hypoglycaemia and glucose variability. Patients choose their preferred frequency (two to six times per week), topics (two or three additionally to hypoglycaemia, which is an obligatory topic), and duration (6 or 9 months). The control group (n = 114) will receive care-as-usual. The primary study endpoint is the HbA1c level after a follow-up of 6 months. The percentage of patients who achieve an HbA1c level ≤ 53 mmol/mol (≤7%) without hypoglycaemia (plasma glucose < 3.5 mmol/L (< 63 mg/dL)) is a co-primary outcome. Secondary outcomes are body mass index, waist circumference, insulin dose, lipid profile, blood pressure, number of hypoglycaemic events, glycaemic variability, self-management (SDSCA), food habits (FFQ), physical activity (IPAQ), health status (EQ-5D-5 L, SF36), diabetes-dependent quality of life (ADDQoL), diabetes treatment satisfaction (DTSQ), satisfaction with the app, the cost-effectiveness of the intervention after 3 months, and sustainability of the intervention effect (3 months extra follow-up in intervention group to compare prolonged to discontinued use of the app). We will use the intention-to-treat principle to analyse data.DiscussionInnovative solutions are needed to improve the (cost-) effectiveness of self-management for the increasing number of T2DM patients. This trial will provide evidence on the effectiveness of a newly developed smartphone app, designed to trigger diabetes self-management.Trial registrationDutch Trial Register NTR5515 , registration date: 18 November 2015 (prospectively registered).

Project description:IntroductionDepression is the leading cause of life years lost due to disability. Appropriate prevention has the potential to reduce the incidence of new cases of depression, however, traditional prevention approaches face significant scalability issues. Prevention programmes delivered by via smartphone applications provide a potential solution. The workplace is an ideal setting to roll out this form of intervention, particularly among industries that are unlikely to access traditional health initiatives and whose workplace characteristics create accessibility and portability issues. The study aims to evaluate the effectiveness of a smartphone application designed to prevent depression and improve well-being. The effectiveness of the app as a universal, selective and indicated prevention tool will also be evaluated.Methods and analysisA multicentre randomised controlled trial, to determine the effectiveness of the intervention compared with an active mood monitoring control in reducing depressive symptoms (primary outcome) and the prevalence of depression at 3 months, with secondary outcomes assessing well-being and work performance. Employees from a range of industries will be invited to participate. Participants with likely current depression at baseline will be excluded. Following baseline assessment, participants, blinded to their allocation, will be randomised to receive one of two versions of the application: headgear (a 30-day mental health intervention) or a control application (mood monitoring for 30 days). Both versions of the app contain a risk calculator to provide a measure of future risk. Analyses will be conducted within an intention-to-treat framework using mixed modelling, with additional analyses conducted to compare the moderating effect of baseline risk level and depression symptom severity on the intervention's effectiveness.Ethics and disseminationThe current trial has received ethics approval from the University of New South Wales Human Research Ethics Committee (HC17021). Study results will be disseminated through peer-reviewed journals and conferences.Trial registration numberACTRN12617000548336; Results.

Project description:ObjectiveTo evaluate the effectiveness of self management as a first line intervention for men with lower urinary tract symptoms.DesignRandomised controlled trial.SettingA teaching hospital and a district general hospital in London.Participants140 men (mean age 63 (SD 10.7) years), recruited between January 2003 and April 2004, referred by general practitioners to urological outpatient departments with uncomplicated lower urinary tract symptoms.InterventionsSelf management and standard care (n=73) or standard care alone (n=67). The self management group took part in three small group sessions comprising education, lifestyle advice, and training in problem solving and goal setting skills.Main outcome measuresThe primary outcome measure was treatment failure measured at 3, 6, and 12 months. Symptom severity (international prostate symptom score; higher scores represent a poorer outcome) was used as a secondary outcome.ResultsAt three months, treatment failure had occurred in 7 (10%) of the self management group and in 27 (42%) of the standard care group (difference=32%, 95% confidence interval 18% to 46%). Corresponding differences in the frequency of treatment failure were 42% (27% to 57%) at six months and 48% (32% to 64%) at 12 months. At three months, the mean international prostate symptom score was 10.7 in the self management group and 16.4 in the standard care group (difference=5.7, 3.7 to 7.7). Corresponding differences in score were 6.5 (4.3 to 8.7) at six months and 5.1 (2.7 to 7.6) at 12 months.ConclusionsSelf management significantly reduced the frequency of treatment failure and reduced urinary symptoms. Because of the large observed benefit of self management, the results of this study support the case for a large multicentre trial to confirm whether self management could be considered as first line treatment for men with lower urinary tract symptoms.Trial registrationNational Research Register N0263115137; Clinical trials NCT00270309 [ClinicalTrials.gov].