scholarly journals The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Maryam Hannah Daud ◽  
Anis Safura Ramli ◽  
Suraya Abdul-Razak ◽  
Mohamad Rodi Isa ◽  
Fakhrul Hazman Yusoff ◽  
...  
2019 ◽  
Author(s):  
Maryam Hannah Daud ◽  
Anis Safura Ramli ◽  
Suraya Abdul-Razak ◽  
Mohamad Rodi Isa ◽  
Noorhida Baharudin ◽  
...  

Abstract Background: Epidemiological studies from various parts of the world have clearly demonstrated that metabolic syndrome (MetS) is an increasing global health problem, not only in the western societies but also in the Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour in patients with MetS components i.e. diabetes or hypertension. However, evidence is lacking in terms of its effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN Self-Management e-Health Intervention in improving patient activation and self-management behaviours among patients with MetS. This paper presents the study protocol. Methods: A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN intervention for 6 months and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model (CCM) and persuasive technology (PT) theory. It consists of training physicians and patients to use the EMPOWER-SUSTAIN web-based self-management intervention mobile apps, strengthening patient-physician relationship and reinforcing the use of relevant clinical practice guidelines (CPG) to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM-13-M) questionnaire. The secondary outcomes include the change in patients’ physical activity level, eating behavior, patients’ perception on chronic illness care, satisfaction in patient-physician interaction and perceived absolute 10-year cardiovascular disease (CVD) risk. Feasibility of implementing the intervention will be evaluated. These include acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and its potential effectiveness. Conclusion: To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial.


2020 ◽  
Author(s):  
Maryam Hannah Daud ◽  
Anis Safura Ramli ◽  
Suraya Abdul-Razak ◽  
Mohamad Rodi Isa ◽  
Fakhrul Hazman Yusoff ◽  
...  

Abstract Background: Epidemiological studies from various parts of the world have clearly demonstrated that Metabolic Syndrome (MetS) is an increasing global health problem, not only in the western societies but also in the Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour in patients with MetS components i.e. diabetes or hypertension. However, evidence is lacking in terms of its effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN © Self-Management e-Health Intervention in improving patient activation and self-management behaviours among patients with MetS. This paper presents the study protocol. Methods: A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients aged 18-60 years old with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN © intervention for 6 months and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN © intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model and persuasive technology theory. It consists of training primary care physicians, nurse and patients to use the EMPOWER-SUSTAIN web-based self-management mobile app © , strengthening patient-physician relationship and reinforcing the use of relevant clinical practice guidelines to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure ® short form Malay version (PAM ® -13-M) questionnaire. The secondary outcomes include the change in waist circumference, body mass index, blood pressure, patients’ physical activity level, eating behavior, patients’ perception on chronic illness care, satisfaction in patient-physician interaction and perceived absolute 10-year cardiovascular disease risk. Feasibility of implementing the intervention will be evaluated. These include acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and its potential effectiveness. Conclusion: To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial.


BMJ Open ◽  
2015 ◽  
Vol 5 (4) ◽  
pp. e006874-e006874 ◽  
Author(s):  
A. R. Neilson ◽  
H. Bruhn ◽  
C. M. Bond ◽  
A. M. Elliott ◽  
B. H. Smith ◽  
...  

2019 ◽  
Vol 13 (2) ◽  
pp. 122-133 ◽  
Author(s):  
Estibaliz Gamboa Moreno ◽  
Maider Mateo-Abad ◽  
Lourdes Ochoa de Retana García ◽  
Kalliopi Vrotsou ◽  
Emma del Campo Pena ◽  
...  

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e040543
Author(s):  
Adam W A Geraghty ◽  
Lisa Roberts ◽  
Jonathan Hill ◽  
Nadine E Foster ◽  
Lucy Yardley ◽  
...  

IntroductionSelf-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.Methods and analysisA three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.Ethics and disseminationThis trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.Trial registration numberISRCTN14736486.


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e027952 ◽  
Author(s):  
Siobhan O'Higgins ◽  
Jennifer Stinson ◽  
Sara Ahola Kohut ◽  
Line Caes ◽  
Caroline Heary ◽  
...  

IntroductionJuvenile idiopathic arthritis (JIA) negatively affects adolescents’ everyday activities. To address the need for innovative, effective, convenient, low-cost psychosocial self-management programmes, we developed an Irish version of Canadian Teens Taking Charge (TTC) and integrated it with Skype-based peer support iPeer2Peer (iP2P).ObjectivesTo explore the feasibility and preliminary outcome impact (effectiveness) of an integrated iP2P and Irish TTC, via three-arm (treatment as usual, TTC and iP2P–TTC) pilot randomised controlled trial (RCT); and determine feasibility and sample size for a full RCT. To ensure active involvement of adolescents with JIA via a Young Person Advisory Panel and examine how participants experienced the study. Finally, to see if TTC and iP2P with TTC reduce costs for families.Methods and analysisRecruitment of 60 families will be ongoing until July 2019, via healthcare professionals and support groups. Analysis will consist of single-blinded (outcome assessment), three-arm pilot RCT, using online questionnaires, with assessments at baseline (T1), after intervention (T2) and 3 months post-intervention (T3). The primary outcomes on feasibility with comparisons of TTC and iP2P–TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring. The secondary outcomes will be self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs.Participants from the intervention groups will be invited to share their perspectives on the process in semistructured interviews. Quantitative data will be analysed using SPSS V.21 and the audio-taped and transcribed qualitative data will be analysed using qualitative content analysis.DisseminationVia journal articles, conference presentations, co-delivered by key stakeholders when possible, launch of accessible, effective and sustainable Internet self-management and peer support for Irish adolescents with JIA.Trial registration numberISRCTN13535901; Pre-results.


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