Dataset Information

Effect of an interactive voice response system on self-management in kidney transplant recipients: Protocol for a randomized controlled trial.

ABSTRACT:

Introduction

Adherence to a complex and ongoing set of therapeutic recommendations significantly determines short and long-term outcomes after kidney transplantation (KT). Interactive voice response system (IVRS) is a novel phone-based platform which is potentially useful to deliver health behavior interventions.

Objective

The aims of the study is to describe the development of a theory-driven and educational IVRS investigate the effect of an IVRS on the self-management outcomes in KT recipients as compared with the control group.

Methods

This study has been designed as a randomized, 2 parallel groups controlled trial. The KT recipients' older than18 years of age with access to a cellphone will be included. A total of 120 patients will be randomly assigned to the control and intervention groups. The participants in the intervention group will receive completely automatic calls in 3 categories: educational, medication adherence, and reminders by the IVRS, whereas those in the control group will receive usual care. The follow up will be performed within 6 months. The primary outcome will be the medication adherence while patients' transplant knowledge, health-related quality of life, and rehospitalization rates will be considered as secondary outcomes.

Results

Thus far, recruitment of participants has not been completed and results will be published in 2019.

Discussion

The IVRS is potentially useful to help KT recipients improve the self-management outcomes. The hypothesis is using an IVRS intervention makes a significant difference between basel assessment of adherence to immunosuppressive medications scale, 12-item short form survey, second version, kidney transplant understanding tool baseline scores, and those obtained at the end of study.

Trial registration number

This trial is registered with the Iran Trial Registrar under registration number IRCT20180124038492N1 and registration date 30 January 2018. https://irct.ir/trial/29215.

SUBMITTER: Ganjali R

PROVIDER: S-EPMC6380874 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Publications

Effect of an interactive voice response system on self-management in kidney transplant recipients: Protocol for a randomized controlled trial.

Ganjali Raheleh R Taherzadeh Zhila Z Ghorban Sabbagh Mahin M Nazemiyan Fatemeh F Mamdouhi Fereshteh F Tabesh Hamed H Badiee Aval Shapour S Golmakani Reza R Mostafavi Sayyed Mostafa SM Eslami Saeid S

Medicine 20190201 6

<h4>Introduction</h4>Adherence to a complex and ongoing set of therapeutic recommendations significantly determines short and long-term outcomes after kidney transplantation (KT). Interactive voice response system (IVRS) is a novel phone-based platform which is potentially useful to deliver health behavior interventions.<h4>Objective</h4>The aims of the study is to describe the development of a theory-driven and educational IVRS investigate the effect of an IVRS on the self-management outcomes i ...[more]

PMID: 30732143

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Project description:BackgroundMonitoring oral anticoagulants is logistically challenging for both patients and medical staff. We evaluated the effect of adding an interactive voice response system to computerized decision support for oral anticoagulant management.MethodsWe developed an interactive voice response system to communicate to patients the results of international normalized ratio testing and their dosage schedules for anticoagulation therapy. The system also reminded patients of upcoming and missed appointments for blood tests. We recruited patients whose anticoagulation control was stable after at least 3 months of warfarin therapy. We prospectively examined clinical data and outcomes for these patients for an intervention period of at least 3 months. We also collected retrospective data for each patient for the 3 months before study enrolment.ResultsWe recruited 226 patients between Nov. 23, 2006, and Aug. 1, 2007. The mean duration of the intervention period (prospective data collection) was 4.2 months. Anticoagulation control was similar for the periods during and preceding the intervention (mean time within the therapeutic range 80.3%, 95% confidence interval [CI] 77.5% to 83.1% v. 79.9%, 95% CI 77.3% to 82.6%). The interactive voice response system delivered 1211 (77.8%) of 1557 scheduled dosage messages, with no further input required from clinic staff. The most common reason for clinic staff having to deliver the remaining messages (accounting for 143 [9.2%] of all messages) was an international normalized ratio that was excessively high or low, (i.e., 0.5 or more outside the therapeutic range). When given the option, 76.6% of patients (164/214) chose to continue with the interactive voice response system for management of their anticoagulation after the study was completed. The system reduced staff workload for monitoring anticoagulation therapy by 48 min/wk, a 33% reduction from the baseline of 2.4 hours.InterpretationInteractive voice response systems have a potential role in improving the monitoring of patients taking oral anticoagulants. Further work is required to determine the generalizability and cost-effectiveness of these results.

Project description:IntroductionSubclinical inflammation is an important predictor of death-censored graft loss, and its treatment has been shown to improve graft outcomes. Urine CXCL10 outperforms standard post-transplant surveillance in observational studies, by detecting subclinical rejection and early clinical rejection before graft functional decline in kidney transplant recipients.Methods and analysisThis is a phase ii/iii multicentre, international randomised controlled parallel group trial to determine if the early treatment of rejection, as detected by urine CXCL10, will improve kidney allograft outcomes. Incident adult kidney transplant patients (n~420) will be enrolled to undergo routine urine CXCL10 monitoring postkidney transplant. Patients at high risk of rejection, defined as confirmed elevated urine CXCL10 level, will be randomised 1:1 stratified by centre (n=250). The intervention arm (n=125) will undergo a study biopsy to check for subclinical rejection and biopsy-proven rejection will be treated per protocol. The control arm (n=125) will undergo routine post-transplant monitoring. The primary outcome at 12 months is a composite of death-censored graft loss, clinical biopsy-proven acute rejection, de novo donor-specific antibody, inflammation in areas of interstitial fibrosis and tubular atrophy (Banff i-IFTA, chronic active T-cell mediated rejection) and subclinical tubulitis on 12-month surveillance biopsy. The secondary outcomes include decline of graft function, microvascular inflammation at 12 months, development of IFTA at 12 months, days from transplantation to clinical biopsy-proven rejection, albuminuria, EuroQol five-dimension five-level instrument, cost-effectiveness analysis of the urine CXCL10 monitoring strategy and the urine CXCL10 kinetics in response to rejection therapy.Ethics and disseminationThe study has been approved by the University of Manitoba Health Research Ethics Board (HS20861, B2017:076) and the local research ethics boards of participating centres. Recruitment commenced in March 2018 and results are expected to be published in 2023. De-identified data may be shared with other researchers according to international guidelines (International Committee of Medical Journal Editors [ICJME]).Trial registration numberNCT03206801; Pre-results.

Project description:BACKGROUND:Optimal self-management in kidney transplant recipients is essential for patient and graft survival, reducing comorbidity and health care costs while improving the quality of life. However, there are few effective interventions aimed at providing self-management support after kidney transplantation. OBJECTIVE:This study aims to systematically develop a nurse-led, self-management (support) intervention for kidney transplant recipients. METHODS:The Intervention Mapping protocol was used to develop an intervention that incorporates kidney transplant recipients' and nurses' needs, and theories as well as evidence-based methods. The needs of recipients and nurses were assessed by reviewing the literature, conducting focus groups, individual interviews, and observations (step 1). Based on the needs assessment, Self-Regulation Theory, and the "5A's" model, change objectives were formulated (step 2). Evidence-based methods to achieve these objectives were selected and subsequently translated into practical implementation strategies (step 3). Then, program materials and protocols were developed accordingly (step 4). The implementation to test the feasibility and acceptability was scheduled for 2015-2017 (step 5). The last step of Intervention Mapping, evaluation of the intervention, falls outside the scope of this paper (step 6). RESULTS:The intervention was developed to optimize self-management (support) after kidney transplantation and targeted both kidney transplant recipients and nurse practitioners who delivered the intervention. The intervention was clustered into four 15-minute sessions that were combined with regular appointments at the outpatient clinic. Nurses received a training syllabus and were trained in communication techniques based on the principles of Solution-Focused Brief Therapy and Motivational Interviewing; this entailed guiding the patients to generate their own goals and solutions and focus on strengths and successes. Kidney transplant recipients were encouraged to assess self-management challenges using the Self-Management Web and subsequently develop specific goals, action plans, and pursuit skills to solve these challenges. CONCLUSIONS:The Intervention Mapping protocol provided a rigorous framework to systematically develop a self-management intervention in which nurses and kidney transplant recipients' needs, evidence-based methods, and theories were integrated. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11856.

Project description:BackgroundKidney transplant outcomes are broadly associated with transplant recipients' capacity in following a complex and continuous self-management regimen. Health information technology has the potential to empower patients. This systematic review aimed to determine the impacts of IT-based interventions for self-management in kidney transplant recipients.MethodsA comprehensive investigation was performed in MEDLINE (via PubMed) and EMBASE (via Scopus) in April 2019. Eligible studies were the randomized controlled trials which aimed to design an automated IT-based intervention. All English papers including adult kidney transplant recipients were included. To assess the clinical trial's quality, Cochrane Collaboration's assessment tool was employed. The articles were integrated based on category of outcomes, characteristics of interventions, and their impact. The interventions were classified based on the used IT-based tools, including smart phones, coverage tools, computer systems, and a combination of several tools. The impact of interventions was defined as: (1) positive effect (i.e. statistically significant), and (2) no effect (i.e. not statistically significant).ResultsA total of 2392 articles were retrieved and eight publications were included for full-text analysis. Interventions include those involving the use of computerized systems (3 studies), smart phone application (3 studies), and multiple components (2 studies). The studies evaluated 30 outcomes in total, including 24 care process and 6 clinical outcomes. In 18 (80%) out of 30 outcomes, interventions had a statistically significant positive effect, 66% in process and 33% in clinical outcomes.ConclusionsIT-based interventions (e.g. mobile health applications, wearable devices, and computer systems) can improve self-management in kidney transplant recipients (including clinical and care process outcomes). However, further evaluation studies are required to quantify the impact of IT-based self-management interventions on short- and long-term clinical outcomes as well as health care costs and patients' quality of life.

Project description:BackgroundAlthough it is well known that compared with dialysis, kidney transplantation improves the quality of life (QoL) of patients with end-stage renal disease, posttransplant recovery of physical health and other aspects of QoL remain well below age- and sex-matched norms. In addition, most transplant recipients are not physically active even years after the transplant and face several barriers to engaging in physical activity (PA). This is of concern as low levels of PA in transplant recipients has been associated with increased risk of mortality and poor graft function. Optimization of QoL needs a team approach involving the patients and the members of the health care team. While members of the health care team are focused on optimizing the biological responses to transplant, patients may have few or no tools at their disposal to engage in behaviors that optimize QoL. To accomplish the need of supporting these patients in the self-management of their condition and to facilitate engagement with PA, new tools tailored to this population are required.ObjectiveThe aim of this protocol study is to develop a Web-based, patient-centered self-management intervention to promote a healthy lifestyle, increase daily PA, and improve QoL in kidney transplant recipients.MethodsWe will use the Obesity-Related Behavioral Intervention Trials model for developing behavioral treatments for chronic diseases to guide the proposed project. We will follow a modified version of the iterative 10-step process that was used to develop educational material for people with multiple sclerosis. The development of the intervention will occur in partnership with patients and a multidisciplinary team of clinicians and researchers. A comprehensive needs assessment including data from our pilot study, literature review, and focus groups will be conducted. The focus groups will be conducted with 6 to 10 participants for each type of stakeholders: patients and professional experts to identify areas of concerns of kidney transplant recipients that are appropriate to address through self-management. The areas of concern identified through the assessment needs will be included in the website.ResultsThis study has received funding from the Kidney Foundation of Canada for 2 years (2018-2020) and was recently granted ethics approval. Investigators have begun conducting the needs assessment described in step 1 of the study. The study is expected to be completed by the end of 2020.ConclusionsThis will be the first comprehensive, evidence- and experience-based self-management program for kidney transplant recipients. Once the intervention is developed, we anticipate improvements in patient experience, shared decision making, daily PA, QoL, and, in future studies, improvements in health outcomes and demonstrations of cost savings in posttransplant care.International registered report identifier (irrid)PRR1-10.2196/13420.

Project description:BackgroundAfter kidney transplantation non-adherence and inadequate self-management undermine clinical outcomes and quality of life. Both have been demonstrated to be substantial in all age groups. However, interventions promoting adherence and self-management among kidney transplant recipients that have proven to be effective are scarce. In this study we aim to develop and test an intervention to optimize adherence and self-management. In this article we describe the background and design of the trial entitled 'promoting Medication AdheRence and Self-management among kidney transplant recipients' (MARS-trial)'.Methods/designThis is a single-center, parallel arm randomized controlled trial. Nonadherent kidney transplant recipients aged 12 years or older are eligible for inclusion. Patients will be randomly assigned to either the experimental or a control group. The control group will receive care-as-usual. The experimental group will receive care-as-usual plus the MARS-intervention. The MARS-intervention is an outreaching intervention, based on the principles of (multi) systemic therapy which means involving the social network. A standardized intervention protocol is used for consistency but we will tailor the behavior change techniques used to the specific needs and determinants of each patient. The primary outcome of medication adherence will be measured using electronic monitoring. Secondary outcome measures regarding medication adherence and self-management are also assessed. Data is collected at baseline (T0), after a run-in period (T1), at six months post-baseline/end of treatment (T2) and after a six month follow-up period (T3).DiscussionWe combined elements of (multi) systemic therapy and evidence-based behavior change techniques to create an outreaching and highly individualized intervention. In this trial we will investigate the impact on medication adherence and self-management after kidney transplantation.Trial registrationNetherlands Trial Register,trial number NTR7462. Registered 7th September 2018, https://www.trialregister.nl/trial/7264.

Project description:BackgroundProviding self-management support to kidney transplant recipients is essential. However, a scale to identify the self-management support they have received is lacking. The purpose of this study is to develop a Self-management Support Scale for Kidney Transplant Recipients (SMSSKTR) and test its psychometric properties.MethodsThis is an instrument development and validation study, which has a three-stage cross-sectional design. In Stage 1, a preliminary item pool was formed using a literature review, semi-structured interviews, and the Delphi method. In Stage 2, six experts were invited to assess content validity. A convenience sample of 313 participants was used to explore the factor structure by using exploratory factor analysis. The test-retest reliability was assessed using the intra-class correlation coefficient (ICC). In Stage 3, two hundred and sixty-five participants were recruited to validate the factor structure by using confirmatory factor analysis. Convergent validity was examined using Spearman's correlation coefficient. Cronbach's alpha coefficient and corrected item-total correlation coefficient were used to test the reliability of the entire scale and its dimensions. The study was reported according to the STARD and GRRAS checklists.ResultsAn initial 40-item scale was developed in Stage 1. In Stage 2, three factors with 22 items emerged from the exploratory factor analysis: instrumental support, psychosocial support, and relational support. The content validity index of the scale was 0.97. The intra-class correlation coefficient for the entire scale and the subscales were 0.915, 0.771, 0.896, and 0.832, respectively. In Stage 3, the confirmatory factor analysis indicated that the three-factor model had a good fit. The score of the scale was positively associated with that of the Self-Management Scale of Renal Transplant Recipients (r = 0.532). Cronbach's alpha was 0.959 for the entire scale and 0.956-0.958 for the three subscales. The corrected item-total correlation coefficient ranged from 0.62 to 0.82.ConclusionThe 22-item SMSSKTR has sufficient psychometric properties to assess the self-management support they have received, which has not been measured before.

Dataset Information

Effect of an interactive voice response system on self-management in kidney transplant recipients: Protocol for a randomized controlled trial.

Introduction

Objective

Methods

Results

Discussion

Trial registration number

Publications

Effect of an interactive voice response system on self-management in kidney transplant recipients: Protocol for a randomized controlled trial.

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