scholarly journals Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Joanna Proctor ◽  
Felix Naughton ◽  
Melanie Sloan ◽  
Sarah Hopewell ◽  
James Brimicombe ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Controlled Trial ◽  
Success Rates ◽  
Behavioral Support ◽  
Randomized Controlled ◽  
The Impact

BACKGROUND The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. OBJECTIVE This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. METHODS The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)—the control—with usual care plus iQuit—the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. RESULTS The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. CONCLUSIONS iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17160

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 Effects of the Proactive Interdisciplinary Self-Management (PRISMA) Program on Online Care Platform Usage in Patients with Type 2 Diabetes in Primary Care: A Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Esther du Pon ◽  
Nanne Kleefstra ◽  
Frits Cleveringa ◽  
Ad van Dooren ◽  
Eibert R. Heerdink ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Online Platform ◽  
Randomized Controlled ◽  
Number Of Patients

Online care platforms can support patients with type 2 diabetes (T2DM) in managing their health. However, in the use of eHealth, a low participation rate is common. The Proactive Interdisciplinary Self-Management (PRISMA) program, aimed at improving patients’ self-management skills, was expected to encourage patients to manage their disease through the use of an online platform. Therefore, the objective of the current study was to investigate whether a group education program can improve the use of an online care platform in patients with T2DM treated by primary care providers in the Netherlands. In a randomized controlled trial, patients with T2DM received either PRISMA with usual care or usual care only. During a six-month follow-up period in 2014-2015, usage (number of log-ons and time spent per session) of an online care platform (e-Vita) aimed at improving T2DM self-management was assessed. A training about the functionalities of e-Vita was offered. The sample consisted of 203 patients. No differences were found between the intervention and control groups in the number of patients who attended the platform training (interested patients) (X21=0.58; p=0.45), and the number of patients who logged on at least once (platform users) (X21=0.46; p=0.50). In addition, no differences were found between the groups in the type of users—patients who logged on twice or more (active users) or patients who logged on once (nonactive users) (X21=0.56; p=0.45). The PRISMA program did not change platform usage in patients with T2DM. In addition, only a small proportion of the patients logged on twice or more. Patients probably need other encouragements to manage their condition using an online platform.

The physical activity counselling (PAC) randomized controlled trial: rationale, methods, and interventions

2007 ◽  
Vol 32 (6) ◽  
pp. 1170-1185 ◽  
Author(s):  
Michelle S. Fortier ◽  
William Hogg ◽  
Tracey L. O’Sullivan ◽  
Christopher Blanchard ◽  
Robert D. Reid ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Care Practice ◽  
Randomized Controlled ◽  
Physical Activity Counselling ◽  
Metabolic Outcomes ◽  
Motivation And Confidence ◽  
The Impact

Primary care is a promising venue to build patient motivation and confidence to increase physical activity (PA). Physician PA counselling has demonstrated some success; however, maintenance of behaviour change appears to require more intensive interventions. In reality, most physicians do not have the necessary training nor the time for this type of counselling. The purpose of this paper is to outline the rationale, methods, and interventions for the ongoing physical activity counselling (PAC) randomized controlled trial (RCT), which aims to assess the impact of integrating a PA counsellor into a primary care practice. This RCT has 2 arms: (i) brief PA counselling (2–4 min) from a health care provider and (ii) brief PA counselling + intensive PA counselling from a PA counsellor (3 months). The impact of this intervention is being evaluated using the comprehensive RE-AIM framework. One hundred twenty insufficiently active adult patients, aged 18 to 69 y and recruited during regular primary care visits have been randomized. Dependent measures include psychological mediators, PA participation, quality of life, and physical and metabolic outcomes. The PAC project represents an innovative, theoretically-based approach to promoting PA in primary care, focusing on psychological mediators of change. We anticipate that key lessons from this study will be useful for shaping future public health interventions, theories, and research.

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