scholarly journals The effectiveness of nurse-led self-management support program for people with chronic kidney disease stage 3-4 (CKD-NLSM): Study protocol for a randomized controlled trial

2021 ◽  
Vol 104 (2) ◽  
pp. 003685042110261
Author(s):  
Al Sawad Ayat Ali ◽  
Soo Kun Lim ◽  
Li Yoong Tang ◽  
Aneesa Abdul Rashid ◽  
Boon-How Chew
Keyword(s):  
Kidney Disease ◽  
Controlled Trial ◽  
Self Management ◽  
Control Group ◽  
Management Support ◽  
Disease Knowledge ◽  
Management Intervention ◽  
Randomized Controlled ◽  
Ckd Stage ◽  
Management Behaviors

The complexity of chronic kidney disease (CKD) and its treatments have made self-management behaviors inevitably challenging. However, supplementing education with self-management skills may improve numerous health outcomes in people with nondialysis CKD. This study protocol describes a randomized controlled trial (RCT) aimed to evaluate the effects of a nurse-led self-management support program as an intervention for kidney disease knowledge and CKD self-management behaviors among people with pre-dialysis CKD. In Phase 1, people with CKD stage 3–4 and their family members are involved in co-designing, development and pilot testing of a theory-based self-management intervention. In Phase 2, we perform a cross-cultural adaptation of the Kidney Disease Knowledge Survey, CKD Self-Management and Self-efficacy for Managing Chronic Disease questionnaires. In Phase 3, a parallel RCT will be conducted to evaluate the intervention where 154 participants with CKD stage 3–4 will be randomly assigned to either the intervention ( n = 77) or control group ( n = 77). The intervention group will receive 6-week self-management program from a nurse-coach in addition to standard usual care, while the control group will receive only standard usual care. Outcome measures include kidney disease knowledge, CKD self-management behavior, self-efficacy, quality of life, blood pressure control and adherence to CKD diet as indicated by 24-h urine urea nitrogen, 24-h urine sodium and net endogenous acid production. Data will be collected at baseline and 12-week post-baseline. The between- and within-group intervention effects will be estimated using the Generalized Estimating Equations. The self-management intervention offers strategies to delay CKD progression and to encourage motivation to better self-manage at home. This study integrates self-management education and psychosocial support with culturally relevant scenarios, and evaluates important self-reported and objective outcomes. Clinical Trials Registration: www.ClinicalTrials.gov , identifier: NCT03974646.

scholarly journals Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Yuki Kawai ◽  
Akiko Sankoda ◽  
Kayo Waki ◽  
Kana Miyake ◽  
Aki Hayashi ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Glycemic Control ◽  
Diabetic Kidney Disease ◽  
Early Stage ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Management Support

BACKGROUND Diabetic kidney disease (DKD) is one of the main complications of type 2 diabetes mellitus (T2DM). DKD is a known risk factor for end-stage renal disease, cardiovascular disease, and all-cause death. Effective intervention for early-stage DKD is vital to slowing down the progression of kidney disease and improve prognoses. Mobile health (mHealth) is reportedly effective in supporting patients’ self-care and improving glycemic control, but the impact of mHealth on DKD has yet to be shown. OBJECTIVE The purpose of this study is to evaluate the efficacy of standard therapy with the addition of a self-management support system, DialBetesPlus, in patients with DKD and microalbuminuria. METHODS This study is a prospective, randomized, open-label, multicenter clinical trial. The target population consists of 160 patients diagnosed with T2DM accompanied by microalbuminuria. We randomly assigned the patients to 2 groups—the intervention group using DialBetesPlus in addition to conventional therapy and the control group using conventional therapy alone. DialBetesPlus is a smartphone application that supports patients’ self-management of T2DM. The study period was 12 months, with a follow-up survey at 18 months. The primary outcome was a change in albuminuria levels at 12 months. Secondary outcomes included changes in physical parameters, blood test results (glycemic control, renal function, and lipid metabolism), lifestyle habits, self-management scores, medication therapy, and quality of life. RESULTS The study was approved in April 2018. We began recruiting patients in July 2018 and completed recruiting in August 2019. The final 18-month follow-up was conducted in March 2021. We recruited 159 patients and randomly allocated 70 into the intervention group and 61 into the control group, with 28 exclusions due to withdrawal of consent, refusal to continue, or ineligibility. The first results are expected to be available in 2021. CONCLUSIONS This is the first randomized controlled trial assessing the efficacy of mHealth on early-stage DKD. We expect that albuminuria levels will decrease significantly in the intervention group due to improved glycemic control with ameliorated self-care behaviors. CLINICALTRIAL UMIN-CTR UMIN000033261; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037924 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/31061

scholarly journals Person-Centered Interactive Self-Management Support in Primary Health Care for People with Type 2 Diabetes: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Ulrika Öberg ◽  
Ulf Isaksson ◽  
Lena Jutterström ◽  
Carljohan Orre ◽  
Åsa Hörnsten
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Management Support ◽  
Randomized Controlled ◽  
Primary Health

BACKGROUND Type 2 diabetes (T2D) is increasing as the population ages. The development of new medical treatments is promising and important, but the basic treatment remains self-management, even if adherence to lifestyle advice is low. Electronic health (eHealth) or mHealth interventions can increase empowerment among people living with T2D and may compensate for the lack of professional resources and geographical distances. The interactive self-management support (iSMS) project aims at including digital tools to support people living with T2D in their self-management and facilitating their interaction with diabetes specialist nurses (DSNs). This protocol outlines a study with the purpose of developing and evaluating an intervention where people living with T2D can increase self-efficacy and empowerment through digital self-monitoring and interaction with DSNs. OBJECTIVE To develop and evaluate a person-centered iSMS intervention in primary health care for people with T2D in addition to their usual diabetes care. METHODS This study is a 12-month, 3-armed, nonblinded randomized controlled trial (RCT), which will be conducted in 6 primary health care centers (HCCs) in northern Sweden. Eligible participants will be randomized to either an intervention group (n=46), a control group (n=46), or an external group (n=46) for comparison. The intervention group will receive the mobile app, and the control group will receive a minimal intervention (diabetes brochure) and the usual standard of care. Changes in glycated hemoglobin (HbA1c) will be the primary outcome measure. RESULTS This trial is currently open for recruitment. The first results are expected to be submitted for publication in Autumn 2019. CONCLUSIONS This study, with its focus on iSMS, will provide insights regarding suitable ways to promote and develop a person-centered intervention. If successful, the intervention has the potential to become a model for the provision of self-management support to people with T2D.

scholarly journals Effects of a Goal-Oriented Intervention on Self-Management Behaviors and Self-Perceived Burden After Acute Stroke: A Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Yu Chen ◽  
Yuanyuan Wei ◽  
Hongjuan Lang ◽  
Ting Xiao ◽  
Yan Hua ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Health Promotion Model ◽  
Randomized Controlled ◽  
Perceived Burden ◽  
Pender's Health Promotion Model ◽  
And Control ◽  
Management Behaviors

Background: Stroke generates significant health and social burdens. Self-management has potential importance for supporting individuals in coping and continuing to progress after stroke. However, there is a lack of targeted programs to enhance self-management and reduce self-perceived burden (SPB) following stroke.Purpose: To evaluate the effects of a goal-oriented intervention on self-management behaviors and SPB among patients after acute stroke.Methods: This was a randomized controlled trial with a 4-weeks intervention. Participants were randomly allocated to the intervention (n = 48) or control group (n = 48). The intervention and control groups received eight sessions of goal-oriented self-management intervention based on Pender's health promotion model and control care, respectively. Self-management behaviors and SPB were evaluated and compared between the two groups.Results: After the 1-month follow-up, there were significant differences in the total self-management behaviors score and the scores of six of the self-management dimensions, excluding diet management, between the intervention group and the control group (t = −7.891– −2.815; p ≤ 0.006). Compared to the control group, the intervention group showed a significant decrease in the physical burden, emotional burden, and total SPB scores (t = 2.102–2.071; p = 0.015–0.041). The economic burden score was not significantly different between the two groups (t = 1.707; p = 0.091).Conclusion: The goal-oriented intervention based on Pender's health promotion model can effectively improve self-management behaviors and reduce physical and emotional SPB among stroke survivors.

scholarly journals The Effects of Telemonitoring on Patient Compliance With Self-Management Recommendations and Outcomes of the Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Hang Ding ◽  
Rajiv Jayasena ◽  
Sheau Huey Chen ◽  
Andrew Maiorana ◽  
Alison Dowling ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Chronic Heart Failure ◽  
Patient Compliance ◽  
Controlled Trial ◽  
Care Program ◽  
Self Management ◽  
Control Group ◽  
Randomized Controlled ◽  
Management Recommendations

BACKGROUND Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but the objective assessment of patient compliance with self-management recommendations has seldom been studied. OBJECTIVE This study aimed to evaluate patient compliance with self-management recommendations of an innovative telemonitoring enhanced care program for CHF (ITEC-CHF). METHODS We conducted a multicenter randomized controlled trial with a 6-month follow-up. The ITEC-CHF program comprised the provision of Bluetooth-enabled scales linked to a call center and nurse care services to assist participants with weight monitoring compliance. Compliance was defined a priori as weighing at least 4 days per week, analyzed objectively from weight recordings on the scales. The intention-to-treat principle was used to perform the analysis. RESULTS A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention. For the compliance criterion of weighing at least 4 days per week, the proportion of compliant participants in the ITEC-CHF group was not significantly higher than that in the control group (ITEC-CHF: 67/91, 74% vs control: 56/91, 60%; <i>P</i>=.06). However, the proportion of ITEC-CHF participants achieving the stricter compliance standard of at least 6 days a week was significantly higher than that in the control group (ITEC-CHF: 41/91, 45% vs control: 23/93, 25%; <i>P</i>=.005). CONCLUSIONS ITEC-CHF improved participant compliance with weight monitoring, although the withdrawal rate was high. Telemonitoring is a promising method for supporting both patients and clinicians in the management of CHF. However, further refinements are required to optimize this model of care. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691

scholarly journals Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial

Pain Medicine ◽  
2019 ◽  
Vol 20 (10) ◽  
pp. 2018-2032 ◽  
Author(s):  
M Bérubé ◽  
C Gélinas ◽  
N Feeley ◽  
G Martorella ◽  
J Côté ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Pain Catastrophizing ◽  
Controlled Trial ◽  
Self Management ◽  
Anxiety And Depression ◽  
Management Intervention ◽  
Randomized Controlled ◽  
Extremity Trauma ◽  
Experimental Group ◽  
Pilot Randomized Controlled Trial

Abstract Objective 1) To assess the feasibility of research methods to test a self-management intervention aimed at preventing acute to chronic pain transition in patients with major lower extremity trauma (iPACT-E-Trauma) and 2) to evaluate its potential effects at three and six months postinjury. Design A pilot randomized controlled trial (RCT) with two parallel groups. Setting A supraregional level 1 trauma center. Methods Fifty-six adult patients were randomized. Participants received the intervention or an educational pamphlet. Several parameters were evaluated to determine the feasibility of the research methods. The potential efficacy of iPACT-E-Trauma was evaluated with measures of pain intensity and pain interference with activities. Results More than 80% of eligible patients agreed to participate, and an attrition rate of ≤18% was found. Less than 40% of screened patients were eligible, and obtaining baseline data took 48 hours postadmission on average. Mean scores of mild pain intensity and pain interference with daily activities (<4/10) on average were obtained in both groups at three and six months postinjury. Between 20% and 30% of participants reported moderate to high mean scores (≥4/10) on these outcomes at the two follow-up time measures. The experimental group perceived greater considerable improvement in pain (60% in the experimental group vs 46% in the control group) at three months postinjury. Low mean scores of pain catastrophizing (Pain Catastrophizing Scale score < 30) and anxiety and depression (Hospital Anxiety and Depression Scale scores ≤ 10) were obtained through the end of the study. Conclusions Some challenges that need to be addressed in a future RCT include the small proportion of screened patients who were eligible and the selection of appropriate tools to measure the development of chronic pain. Studies will need to be conducted with patients presenting more serious injuries and psychological vulnerability or using a stepped screening approach.

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