Category
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Primary study
Registry of Trials»ANZCTR
Year
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2017
INTERVENTION: The intervention consists of: 1. Three training modules of approximately 3 hours duration. These will be offered on an on‐line platform (Smart Sparrow) which is an interactive eLearning courseware used at the University of NSW. Both GPs and practice nurses will access these modules in their own time. These will focus on the principles of health literacy and clinical weight management. The modules will also overview study protocols and processes including patient enrolment , the process for conducting health assessments, registering patients with the lifestyle app (My SNAPP), and procedures to ensure patients are followed up and referred to Get Healthy telephone counselling. 2. A medical record audit of practice data performed using Doctors Control Panel (DCP) software. We will use a de‐identified audit to illustrate the completeness of practice recording of risk factors and the same variables will be collected on eligible, consenting patients at baseline, 12 months and 18 months. This will be managed by the Field Research Officer (FRO) . 3. Three practice facilitation visits will be provided by a trained facilitator from a local Primary Health Network (PHN). Each face to face visit will be of 1‐1.5hrs duration and provided at intervals during the 6‐month intervention period. The aim of the practice facilitation is to support general practices in the intervention arm of the HeLP trial to implement effective preventive care which is tailored to the needs of, and develops the knowledge and skills of overweight patients with low health literacy. Facilitators will receive training on the delivery of the sessions and will document these using a facilitator diary. 4. A health check visit for eligible and consenting patients will be undertaken within 4 weeks of recruitment performed by the Practice Nurse. This will utilise the 5As framework (assess, advise, agree, assist and arrange) and cover the following: Assess ‐ Review baseline BMI, waist circumference, diet and physical activity, cardiovascular and diabetes risk, language and health literacy. Advise/ Agree ‐ Provide brief advice using video vignettes; check patient understanding using teach‐back method; download and log into My SNAPP (an app developed for the trial available on smart phone and tablet); work with each patient to register for the app, set up their profile and instruct them on the use of the app. Assist ‐ Introduce the Get Healthy telephone coaching program to the patient, (outline purpose of the program and details about participation). If the patient wants to participate, ‘assisted referral’ is made to the program in the presence of the patient. Get Healthy will provide tailored patient lifestyle coaching over 10 one‐hour sessions. Coaches are trained by Get Healthy to deliver coaching sessions. Arrange ‐ Arrange follow up communication and a second visit with the practice nurse at 6 weeks and with the GP at 12 weeks. A 12 month review will be provided by the GP. Fidelity of the intervention will be assessed by the following measures: • % of intervention patients who receive health check at baseline, 6 week reviews by the practice nurse and 12 week review by the GP • % who received ‘assisted referral to the Get Healthy telephone counselling service (English speaking/Arabic speaking) • % of patients who take up (one or more sessions) of the Get Healthy telephone coaching program (English speaking/Arabic speaking) • % of patients who complete the Get Healthy program (English speaking/Arabic speaking). Completion is defined as completing six of the 10 allocated sessions) CONDITION: Chronic disease Low health literacy Obesity PRIMARY OUTCOME: Biomedical risk factors (weight, waist circumference, BMI, blood pressure) assessed through audit of clinical records eHealth literacy • Usage of My SNAPP determined by Healthy.me captured analytics (% of patients with documented goals related to lifestyle change; usage data including number of times app accessed; number of pages accessed) ; ; eHealth literacy assessed using the e Health Literacy Scale (eHeals) delivered by a researcher using a telephone interview. The eHEALS is an 8‐item measure of eHealth literacy developed to measure consumers’ combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems. Health literacy ; ; Health literacy assessed using the Health Literacy Questionaire (HLQ) delivered by a researcher using a telephone interview. We will assess changes between baseline, 6 and 12 months compared by group on individual validated questions from this questionnaire SECONDARY OUTCOME: Behavioural risk factors (Daily fruit and vegetable consumption) assessed from self‐reported information via telephone survey ; Behavioural risk factors (physical activity level) assessed from self‐reported information via telephone survey ; Cost of the intervention. We will use MBS and PBS data and public hospital data from the State Health Departments to assess the cost of the intervention. The MBS, PBS and State data will capture most primary care costs. Non‐charged PN visits will be assigned an hourly rate based on PN salary levels plus on‐costs. Questions on patient costs in accessing lifestyle services and programs, and non‐Medicare funded allied health will be included in the patient questionnaire. Cost estimates will be generated for referrals to community based programs. In the base case analysis, undertaken from a health service perspective, referrals to allied health professionals will only be costed if supported by a Medicare claim. The incremental costs of the intervention, will be presented alongside the consequences with respect to changes in quality of life (in the form of QALY gains informed by the EQ5D‐5L) and differences in health literacy, behavioural outcomes, and clinical measures (BMI, blood pressure and Lipids). Deterministic and bootstrapped sensitivity analyses will be undertaken to identify key uncertain parameters and represent uncertainty around the mean estimates, respectively. Health related Quality of Life (QoL) measured by the EQ‐5D‐5L ‐ data collected from a telephone survey administered by a researcher. Receipt of advice on diet. Self reported via a telephone survey Receipt of advice on physical activity Self reported via a telephone survey Receipt of advice on smoking. Self reported via a telephone survey Receipt of advice on weight management Self reported via a telephone survey Total cholesterol INCLUSION CRITERIA: Situated in Local Government Areas (LGAs) with a SEIFA score equal to or below the 6th decile • Using Medical Director PracSoft or Best Practice software and allocate patients to individual GPs within this software • Agree to the use of Doctors Control Panel (DCP) linked with their software to identify eligible patients for the study • Have access to an active internet connection • Have at least one practice nurse who is prepared to conduct the HeLP intervention with eligible patients and complete data management relating to these patients • Agree to provide GP follow up health checks to participating patients at 12 weeks and 12 month time points • Can make their reception staff available to distribute study materials to potential study participants as they present to the practice Patients: • Aged 40‐74 years and living in postcodes of interest • Overweight or obese (BMI=/> 28 recorded in last 12 months) • Speaking Englis
Epistemonikos ID: cef701d5e77f841a2565a3028b06928064aceb47
First added on: Aug 25, 2024