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The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial.

ABSTRACT: Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease.The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial.The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage.Trial registration reference: ISRCTN45433299.

SUBMITTER: Blickem C

PROVIDER: S-EPMC3599273 | biostudies-other | 2013 Jan

REPOSITORIES: biostudies-other

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The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial.

Blickem Christian C Blakeman Tom T Kennedy Anne A Bower Peter P Reeves David D Gardner Caroline C Lee Victoria V Chew-Graham Carolyn C Richardson Gerry G Brooks Helen H Dawson Shoba S Mossabir Rahena R Jariwala Praksha P Swallow Angela A Kontopantelis Evan E Gaffney Hannah H Small Nicola N Spackman Eldon E Rogers Anne A

Trials 20130128

<h4>Background</h4>Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chroni ...[more]

PMID: 23356861

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Project description:BACKGROUND:Cognitive behavioral therapy (CBT) is frequently used to treat depressive symptoms in people living with HIV. We developed an internet-based cognitive behavioral intervention for people with HIV and depressive symptoms, which was based on an effective self-help booklet. The Web-based intervention was previously found to be effective. OBJECTIVE:The objective of this study was to investigate potential mediators of the Web-based intervention. METHODS:This study was part of a randomized controlled trial, in which the intervention was compared with an attention-only waiting list control condition. Participants were 188 (97 in intervention group and 91 in control group) people with HIV and mild to moderate depressive symptoms recruited in HIV treatment centers in the Netherlands. A total of 22 participants (22/188, 11.7%) in the study were female and 166 (166/188, 88.3%) were male. The average age of the participants was 46.30 years (SD 10.63). The intervention comprised Web-based self-help CBT for 8 weeks, 1 to 2 hours a week, including minimal telephone support from a coach. The participants received Web-based questionnaires at pretest, 3 times during the intervention/or waiting period, and post intervention. The outcome was depressive symptoms. Factors tested as potential mediators were changes in behavioral activation, relaxation, the cognitive coping strategies catastrophizing and positive refocusing, goal re-engagement, and coping self-efficacy. RESULTS:Using multilevel structural equation modeling, changes in behavioral activation (P=.006) and goal re-engagement (P=.009) were found to be significant mediators of the intervention effect. The mediation effect seemed to occur between weeks 3 and 5 for behavioral activation and weeks 1 and 3 for goal re-engagement. Using (bivariate) autoregressive latent trajectory analysis, we found a return effect (from the dependent variable to the mediator) for goal re-engagement but not for behavioral activation, which suggested that the mediation effect of changes in behavioral activation was stronger than that in goal re-engagement. CONCLUSIONS:The results suggest that changes in behavioral activation and goal re-engagement may mediate the effect of the Web-based intervention for people with HIV and depressive symptoms. The results may lead to possible mechanisms of change of the intervention and improvement of therapy outcomes. TRIAL REGISTRATION:Netherlands Trial Register NTR5407; https://www.trialregister.nl/trial/5298.

Project description:BackgroundThe diagnosis and treatment of a brain or spinal cord tumour can have a huge impact on the lives of patients and their families with family caregiving often resulting in considerable burden and distress. Meeting the support needs of family caregivers is critical to maintain their emotional and physical health. Although support for caregivers is becoming more widely available, large-scale implementation is hindered by a lack of high-quality evidence for its effectiveness in the neuro-oncology caregiver population.ObjectivesTo assess the effectiveness of supportive interventions at improving the well-being of caregivers of people with a brain or spinal cord tumour. To assess the effects of supportive interventions for caregivers in improving the physical and emotional well-being of people with a brain or spinal cord tumour and to evaluate the health economic benefits of supportive interventions for caregivers.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), MEDLINE via Ovid, and Embase via Ovid. We also handsearched relevant published conference abstracts (previous five years), publications in the two main journals in the field (previous year), searched for ongoing trials via ClinicalTrials.gov, and contacted research groups in the field. The initial search was in March 2017 with an update in August 2018 (handsearches completed in January 2019).Selection criteriaWe included all randomised controlled trials (RCTs) where caregivers of neuro-oncology patients constituted more than 20% of the sample and which evaluated changes in caregiver well-being following any supportive intervention.Data collection and analysisTwo review authors independently selected studies and carried out risk of bias assessments. We aimed to extract data on the outcomes of psychological distress, burden, mastery, quality of patient-caregiver relationship, quality of life, and physical functioning.Main resultsIn total, the search identified 2102 records, of which we reviewed 144 in full text. We included eight studies. Four interventions focused on patient-caregiver dyads and four were aimed specifically at the caregiver. Heterogeneity of populations and methodologies precluded meta-analysis. Risk of bias varied, and all studies included only small numbers of neuro-oncology caregivers (13 to 56 participants). There was some evidence for positive effects of caregiver support on psychological distress, mastery, and quality of life (low to very low certainty of evidence). No studies reported significant effects on caregiver burden or quality of patient-caregiver relationship (low to very low certainty of evidence). None of the studies assessed caregiver physical functioning. For secondary outcomes (patient emotional or physical well-being; health economic effects), we found very little to no evidence for the effectiveness of caregiver support. We identified five ongoing trials.Authors' conclusionsThe eight small-scale studies included employed different methodologies across different populations, with low certainty of evidence overall. It is not currently possible to draw reliable conclusions regarding the effectiveness of supportive interventions aimed at improving neuro-oncology caregiver well-being. More high-quality research is needed on support for family caregivers of people diagnosed, and living, with a brain or spinal cord tumour.

Project description:BackgroundAbout three-quarters of people with dementia live in their own homes, with help from family members and/or other unpaid carers, such as friends or neighbors. Often, unpaid carers themselves experience negative consequences, such as stress, burden, and symptoms of depression or anxiety. Research has shown that these consequences can be alleviated by psychosocial and psychological interventions. Moreover, there are indications that those interventions can be effective when offered online.ObjectiveThis paper describes the protocol of a randomized controlled trial (RCT) that will take place in the Netherlands to evaluate the effectiveness of iSupport, a minimally guided, internet-based intervention to improve carers' mental health and coping resources.MethodsA superiority two-arm RCT comparing the effects of the online support program with a waiting list control condition will be carried out in the Netherlands. The iSupport intervention was developed by the World Health Organization and is based on cognitive behavioral therapy principles. It has five main themes divided into 23 lessons. Carers can pick and choose which lessons they want to complete. We aim to recruit 200 unpaid carers. The experimental group (n=100) will be provided with access to the intervention for 3 months following randomization; those in the waiting list control group (n=100) will be granted access to the intervention after 3 months. Assessments will be conducted at baseline (T0), 3 months after baseline (post intervention, T1), and 6 months after baseline (follow-up, T2). The primary outcome is perceived stress, measured by the Perceived Stress Scale. Secondary outcomes are symptoms of depression and anxiety, caregiver burden, sense of competence, self-efficacy, mastery, and carers' attitudes toward dementia and their person-centered approach (ie, to what extent carers tailor the provided care to the interest, needs, and history of the person with dementia).ResultsRecruitment for the trial started in January 2019. As of July 2019, we have enrolled 120 participants. Data collection is expected to be completed by March 2020. Once all the data have been collected, we will conduct the data analyses between April and May 2020. We aim to publish our results in a manuscript by June 2020.ConclusionsOnline interventions have shown promising results in improving the mental health of carers of people with dementia. Additionally, online interventions may overcome accessibility barriers. If successful, this intervention will have important potential for implementation as a public health intervention, since costs and support by trained staff are minimal.Trial registrationNetherlands Trial Register (NTL) NL6417; https://www.trialregister.nl/trial/6417.International registered report identifier (irrid)DERR1-10.2196/14106.

Project description:OBJECTIVES:To ascertain whether an ultrabrief intervention (UBI) improves mental health outcomes for patients in general practice with mild-to-moderate mental health concerns. TRIAL DESIGN:Two-arm cluster randomised controlled trial. METHODS:Participants: general practitioners (GPs) were invited based on working in a participating general practice. Patients were eligible to participate if aged 18-65 years, scored ?35 on the Kessler-10 (K10) and if meeting local mental health access criteria (based on age, low income or ethnic group). INTERVENTIONS:intervention arm GPs were trained on the UBI approach, with participating patients receiving three structured appointments over 5 weeks. GPs randomised to practice as usual (PAU) did not receive training, and delivered support following their existing practice approaches. OUTCOME MEASURES:primary outcome was patient-level K10 score at 6 months postrecruitment.Randomisation: GP practices were randomised to UBI training or PAU at the start of the study.Blinding: GPs were not blinded to group assignment. RESULTS:Numbers randomised: 62 GPs (recruiting 85 patients) were randomised to UBI, and 50 to PAU (recruiting 75 patients).Numbers analysed: 31 GPs recruited at least one patient in the UBI arm (70 patients analysed), and 21 GPs recruited at least one patient in the PAU arm (69 patients analysed). OUTCOME:K10 scores from an intention-to-treat analysis were similar in UBI and PAU arms, with a wide CI (mean adjusted K10 difference=1.68 points higher in UBI arm, 95% CI -1.18 to 4.55; p=0.255). Secondary outcomes were also similar in the two groups. CONCLUSIONS:the UBI intervention did not lead to better outcomes than practice as usual, although the study had lower than planned power due to poor recruitment. The study results can still contribute to the continuing debate about brief psychological therapy options for primary care and their development. TRIAL REGISTRATION NUMBER:ACTRN12613000041752; Pre-results.

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The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial.

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The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial.

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