scholarly journals OXTR rs53576 variation with breast and nipple pain in breastfeeding women

2020 ◽  
Author(s):  
Ruth F Lucas ◽  
Yiming Zhang ◽  
Stephen Walsh ◽  
Angela Starkweather ◽  
Erin Young
Keyword(s):  
Pain Sensitivity ◽  
Controlled Trial ◽  
Detection Threshold ◽  
Minor Allele ◽  
Pain Severity ◽  
Self Management ◽  
Sensitivity Testing ◽  
Targeted Interventions ◽  
Breastfeeding Cessation ◽  
Oxtr Rs53576

Purpose: To evaluate associations among breast and nipple pain sensitivity and candidate pain sensitivity single-nucleotide polymorphisms [SNPs], (COMT rs6269, rs4633, rs4818, rs4680 and OXTR rs2254298, rs53576) in breastfeeding women. Design: A secondary analysis of sixty women participating in a pilot randomized controlled trial of a pain self-management intervention. Methods: All participants underwent standardized mechanical somatosensory testing for an assessment of pain sensitivity and provided baseline buccal swabs for genetic analysis. At 1, 2, and 6 weeks postpartum, women self-reported breast and nipple pain severity using a visual analogue scale. Results:- Women with the minor allele OXTR rs53576 reported 8.18-fold higher breast and nipple pain severity over time. For every 1-unit increase in mechanical detection threshold and windup ratio, women reported 16.51-fold and 4.82-fold higher breast and nipple pain severity respectively. Six women with the OXTR rs2254298 minor allele reported allodynia. Discussion: The presence of OXTR alleles in women with enhanced pain sensitivity suggests a phenotype of genetic risk for ongoing breast and nipple with potential for pain-associated breastfeeding cessation. Somatosensory testing identified women who reported higher breast and nipple pain during the first weeks of breastfeeding. Clinical Implications: Pain sensitivity testing can help to identify women at risk of intolerable and/or ongoing breastfeeding pain who may benefit from additional support to mitigate early breastfeeding cessation. Targeted interventions are needed to address breastfeeding pain, including management of infant latch, positioning, and infection as well as support for self-management of breastfeeding pain.

A patient-centered mobile intervention to promote self-management and improve patient outcomes in chronic heart failure: The ManageHF4Life trial (Preprint)

2020 ◽  
Author(s):  
Michael P. Dorsch ◽  
Karen B. Farris ◽  
Brigid E. Rowell ◽  
Scott L. Hummel ◽  
Todd M. Koelling
Keyword(s):  
Heart Failure ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Self Management ◽  
Control Group ◽  
Patient Centered ◽  
Self Monitoring ◽  
Heart Failure Questionnaire

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510

scholarly journals Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Peter Neal ◽  
Yvonne J. F. Kerkhof ◽  
Teake P. Ettema ◽  
Majon Muller ◽  
Judith Bosmans ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Social Participation ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Self Management ◽  
Tablet Computer ◽  
Randomized Controlled ◽  
People With Dementia

Abstract Background For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. Methods A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm – tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm – tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. Discussion Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. Trial registration number Netherlands Trial Register: NL8157; registered 15th November 2019.

scholarly journals EXPRESS: Telehealth coaching to improve self-management for secondary prevention after stroke: A randomized controlled trial of Stroke Coach

2021 ◽  
pp. 174749302110176
Author(s):  
Brodie M Sakakibara ◽  
Scott A Lear ◽  
Susan I Barr ◽  
Charles Goldsmith ◽  
Amy Schneeberg ◽  
...  
Keyword(s):  
Risk Factors ◽  
Controlled Trial ◽  
Cognitive Status ◽  
Self Management ◽  
Community Living ◽  
Memory Training ◽  
Stroke Survivors ◽  
Post Intervention ◽  
Lifestyle Behaviour ◽  
Mild Stroke

Background: Stroke Coach is a lifestyle coaching telehealth program to improve self-management of stroke risk factors. Aims: To examine the efficacy of Stroke Coach on lifestyle behaviour and risk factor control among community-living stroke survivors within one-year post stroke. Methods: Participants were randomized to Stroke Coach or an attention control Memory Training group. Lifestyle behaviour was measured using the Health Promoting Lifestyle Profile II. Secondary outcomes included specific behavioural and cardiometabolic risk factors, health-related quality of life (HRQoL), cognitive status, and depressive symptoms. Measurements were taken at baseline, post-intervention (6 months), and retention (12 month). Linear mixed-effects models were used to test the study hypotheses (p<0.05). All analyses were intention-to-treat. Results: The mean age of the Stroke Coach (n=64) and Memory Training (n=62) groups was 67.2 and 69.1 years, respectively. The majority of participants (n = 100) had mild stroke (modified Rankin Scale = 1 or 2), were active, with controlled blood pressure (mean = 129/79 mmHg) at baseline. At post-intervention, there were no significant differences in lifestyle (b = -2.87; 95%CI -8.03 to 2.29; p=0.28). Glucose control, as measured by HbA1c (b = 0.17; 95%CI 0.17 to 0.32; p=0.03), and HRQoL, measured using SF-36 Physical Component Summary (b = -3.05; 95%CI -5.88 to -0.21; p=0.04), were significantly improved in Stroke Coach compared to Memory Training, and the improvements were maintained at retention. Conclusion: Stroke Coach did not improve lifestyle behaviour, however, there were improvements to HbA1c and HRQoL among community-living stroke survivors with mild stroke-related disability. (ClinicalTrials.gov identifier: NCT02207023)

scholarly journals Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness–implementation randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e048350
Author(s):  
Monika Kastner ◽  
Julie Makarski ◽  
Leigh Hayden ◽  
Jemila S Hamid ◽  
Jayna Holroyd-Leduc ◽  
...  
Keyword(s):  
Older Adults ◽  
Chronic Disease ◽  
Randomised Controlled Trial ◽  
Disease Management ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Management Tool ◽  
Self Management ◽  
Plain Language ◽  
Randomised Controlled

IntroductionIn response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called ‘KeepWell’ that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.Methods and analysisWe will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness–implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.Ethics and disseminationEthics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.Trial registration numberNCT04437238.

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 Feasibility study of real-time online text-based CBT to support self-management for people with type 1 diabetes: the Diabetes On-line Therapy (DOT) Study

2021 ◽  
Vol 9 (1) ◽  
pp. e001934
Author(s):  
Anne M Doherty ◽  
Anne Herrmann-Werner ◽  
Arann Rowe ◽  
Jennie Brown ◽  
Scott Weich ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Real Time ◽  
Instant Messaging ◽  
Controlled Trial ◽  
Self Management ◽  
Diabetes Distress ◽  
The Mean ◽  
Distress Scale

IntroductionThis study examines the feasibility of conducting diabetes-focused cognitive–behavioral therapy (CBT) via a secure online real-time instant messaging system intervention to support self-management and improve glycemic control in people with type 1 diabetes.Research design and methodsWe used a pre–post uncontrolled intervention design over 12 months. We recruited adults with type 1 diabetes and suboptimal glycemic control (HbA1c ≥69 mmol/mol (DCCT 8.5%) for 12 months) across four hospitals in London. The intervention comprised 10 sessions of diabetes-focused CBT delivered by diabetes specialist nurses. The primary outcomes were number of eligible patients, rates of recruitment and follow-up, number of sessions completed and SD of the main outcome measure, change in HbA1c over 12 months. We measured the feasibility of collecting secondary outcomes, that is, depression measured using Patient Health Questionnaire-9 (PHQ-9), anxiety measured Generalised Anxiety Disorder (GAD) and the Diabetes Distress Scale (DDS).ResultsWe screened 3177 patients, of whom 638 were potentially eligible, from whom 71 (11.1%) were recruited. The mean age was 28.1 (13.1) years, and the mean HbA1c was 84.6 mmol/mol (17.8), DCCT 9.9%. Forty-six (65%) patients had at least 1 session and 29 (41%) completed all sessions. There was a significant reduction in HbA1c over 12 months (mean difference −6.2 (2.3) mmol/mol, DCCT 0.6%, p=0.038). The change scores in PHQ-9, GAD and DDS also improved.ConclusionsIt would be feasible to conduct a full-scale text-based synchronized real-time diabetes-focused CBT as an efficacy randomized controlled trial.

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