scholarly journals Effects of a Text Messaging Smoking Cessation Intervention Among Online Help Seekers and Primary Health Care Visitors in Sweden: Protocol for a Randomized Controlled Trial Using a Bayesian Group Sequential Design

10.2196/23677 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e23677
Author(s):  
Marcus Bendtsen ◽  
Kristin Thomas ◽  
Catharina Linderoth ◽  
Preben Bendtsen
Keyword(s):  
Health Care ◽  
Smoking Cessation ◽  
Primary Health Care ◽  
General Population ◽  
Text Messaging ◽  
Controlled Trial ◽  
Group Sequential Design ◽  
Group Sequential ◽  
Randomized Controlled ◽  
Primary Health

Background A steady decline of the smoking prevalence in Sweden has been recorded over the past decade; however, people still start and continue to smoke. There is a need for effective smoking cessation interventions that can scale to a national level and that are designed to reach individuals requiring smoking cessation support in the general population. Objective Previous randomized controlled trials of smoking cessation interventions among high school and university students in Sweden have found consistent evidence that text messaging interventions are effective in helping students quit smoking. However, there are no studies that investigate the effects of text messaging interventions in a more general population. The objective of this study is to estimate the effects of a text messaging intervention on individuals seeking help to quit online and individuals visiting primary health care units. Methods A 2-arm, parallel-group (1:1), randomized controlled trial will be employed to address the study objectives. The trial will follow a Bayesian group sequential design. Recruitment will be conducted using online advertisement (Google, Bing, and Facebook) and through health care professionals at primary health care units. All participants will receive treatment as usual; however, participants who are allocated to the intervention arm will also be given access to a 12-week text message smoking cessation intervention. Primary outcomes are 8-week prolonged abstinence and 4-week point prevalence, measured 3 months and 6 months postrandomization. Mediator variables (self-efficacy, importance, and know-how) will be measured to estimate causal mediation models. Results Recruitment commenced in September 2020 and will not exceed 24 months. This means that a complete dataset will be available at the latest towards the end of 2022. We expect to publish the findings from this trial by June 2023. Conclusions This trial will further our understanding of the effects of text messaging interventions among a more general population than has previously been studied. We also aim to learn about differential effects between those who seek support online and those who are given facilitated support at primary health care units. Trial recruitment is limited to the Swedish population; however, a strength of this study is the pragmatic way in which participants are recruited. Through online advertisements, individuals are recruited in reaction to their own interest in seeking help to quit. At primary health care units, individuals who were not necessarily looking for smoking cessation support are given information about the trial. This closely mimics the way the intervention would be disseminated in a real-world setting and may therefore strengthen the argument of generalizability of findings. Trial Registration ISRCTN 13455271; http://www.isrctn.com/ISRCTN13455271. International Registered Report Identifier (IRRID) PRR1-10.2196/23677

scholarly journals Effects of a Text Messaging Smoking Cessation Intervention Among Online Help Seekers and Primary Health Care Visitors in Sweden: Protocol for a Randomized Controlled Trial Using a Bayesian Group Sequential Design (Preprint)

2020 ◽  
Author(s):  
Marcus Bendtsen ◽  
Kristin Thomas ◽  
Catharina Linderoth ◽  
Preben Bendtsen
Keyword(s):  
Health Care ◽  
Smoking Cessation ◽  
Primary Health Care ◽  
General Population ◽  
Text Messaging ◽  
Controlled Trial ◽  
Group Sequential Design ◽  
Group Sequential ◽  
Randomized Controlled ◽  
Primary Health

BACKGROUND A steady decline of the smoking prevalence in Sweden has been recorded over the past decade; however, people still start and continue to smoke. There is a need for effective smoking cessation interventions that can scale to a national level and that are designed to reach individuals requiring smoking cessation support in the general population. OBJECTIVE Previous randomized controlled trials of smoking cessation interventions among high school and university students in Sweden have found consistent evidence that text messaging interventions are effective in helping students quit smoking. However, there are no studies that investigate the effects of text messaging interventions in a more general population. The objective of this study is to estimate the effects of a text messaging intervention on individuals seeking help to quit online and individuals visiting primary health care units. METHODS A 2-arm, parallel-group (1:1), randomized controlled trial will be employed to address the study objectives. The trial will follow a Bayesian group sequential design. Recruitment will be conducted using online advertisement (Google, Bing, and Facebook) and through health care professionals at primary health care units. All participants will receive treatment as usual; however, participants who are allocated to the intervention arm will also be given access to a 12-week text message smoking cessation intervention. Primary outcomes are 8-week prolonged abstinence and 4-week point prevalence, measured 3 months and 6 months postrandomization. Mediator variables (self-efficacy, importance, and know-how) will be measured to estimate causal mediation models. RESULTS Recruitment commenced in September 2020 and will not exceed 24 months. This means that a complete dataset will be available at the latest towards the end of 2022. We expect to publish the findings from this trial by June 2023. CONCLUSIONS This trial will further our understanding of the effects of text messaging interventions among a more general population than has previously been studied. We also aim to learn about differential effects between those who seek support online and those who are given facilitated support at primary health care units. Trial recruitment is limited to the Swedish population; however, a strength of this study is the pragmatic way in which participants are recruited. Through online advertisements, individuals are recruited in reaction to their own interest in seeking help to quit. At primary health care units, individuals who were not necessarily looking for smoking cessation support are given information about the trial. This closely mimics the way the intervention would be disseminated in a real-world setting and may therefore strengthen the argument of generalizability of findings. CLINICALTRIAL ISRCTN 13455271; http://www.isrctn.com/ISRCTN13455271. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/23677

scholarly journals Health TAPESTRY Ontario: Protocol for a Randomized Controlled Trial to Test Reproducibility and Implementation

2020 ◽  
Author(s):  
Dee Mangin ◽  
Larkin Lamarche ◽  
Sivan Bomze ◽  
Sayem Borhan ◽  
Tracy Browne ◽  
...  
Keyword(s):  
Physical Activity ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Primary Health Care ◽  
Controlled Trial ◽  
Care Team ◽  
Control Group ◽  
Randomized Controlled ◽  
Primary Health ◽  
Diverse Communities

Abstract Background: Health TAPESTRY (Health Teams Advancing Patient Experience: STRengthening qualitY) aims to help people stay healthier for longer where they live by providing person-focused care through the integration of four key program components: 1) trained volunteers who visit clients in their homes, 2) an interprofessional primary health care team, 3) use of technology to collect and share information, and 4) improved connections to community health and social services. The initial randomized controlled trial of Health TAPESTRY found promising results in terms of health care use and patient outcomes, indicating a shift from reactive to preventive care. The trial was based on one clinical academic centre, thus limiting generalizability. The study objectives are: 1) to test reproducibility of the established effectiveness of Health TAPESTRY on physical activity and hospitalizations, 2) to test the feasibility of, and understand the contributing factors to, the implementation of Health TAPESTRY in six diverse communities across Ontario, Canada, and 3) to determine the value for money of implementing Health TAPESTRY. Methods : This planned study is a pragmatic parallel randomized controlled trial with a delayed intervention for control participants at six months. This trial will simultaneously assess effectiveness and implementation in a real world setting (Type II hybrid) in six diverse communities across Ontario. Participants 70 years of age and older will be randomized into the Health TAPESTRY intervention or the control group (usual care). Intervention clients will receive an individualized plan of care from an interprofessional care team. The plan will be based on a client’s goals and current health risks identified through volunteer visits. The study’s outcomes are mapped onto the RE-AIM framework, with levels of physical activity and number of hospitalizations as the co-primary outcomes. The main analysis will be a comparison at six months. Discussion: It is important to evaluate the effectiveness and implementation of Health TAPESTRY in multiple communities prior to scaling or widespread adoption. Trial registration: ClinicalTrials.gov: NCT03397836 (posted January 12, 2018). Keywords: Primary health care, Randomized controlled trial, Integrated care, Interdisciplinary health care teams, Health care volunteers, Older adults, Implementation

scholarly journals Does mhGAP training of primary health care providers improve the identification of child- and adolescent mental, neurological or substance use disorders? Results from a randomized controlled trial in Uganda

2018 ◽  
Vol 5 ◽  
Author(s):  
A. Akol ◽  
F. Makumbi ◽  
J. N. Babirye ◽  
J. S. Nalugya ◽  
S. Nshemereirwe ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Primary Health Care ◽  
Health Care Providers ◽  
Controlled Trial ◽  
Child And Adolescent ◽  
Care Providers ◽  
Randomized Controlled ◽  
Primary Health

Background.Integrating child and adolescent mental health (CAMH) into primary health care (PHC) using the WHO mental health gap action program (mhGAP) is recommended for closing a mental health treatment gap in low- and middle-income countries, but PHC providers have limited ability to detect CAMH disorders. We aimed to evaluate the effect of PHC provider mhGAP training on CAMH disorder identification in Eastern Uganda.Methods.Thirty-six PHC clinics participated in a randomized controlled trial which compared the proportion of intervention (n= 18) to control (n= 18) clinics with a non-epilepsy CAMH diagnosis over 3 consecutive months following mhGAP-oriented CAMH training. Fisher's exact test and logistic regression based on intention to treat principles were applied. (clinicaltrials.gov registration NCT02552056).Results.Nearly two thirds (63.8%, 23/36) of all clinics identified and recorded at least one non-epilepsy CAMH diagnosis from 40 692 clinic visits of patients aged 1–18 recorded over 4 months. The proportion of clinics with a non-epilepsy CAMH diagnosis prior to training was 27.7% (10/36, similar between study arms). Training did not significantly improve intervention clinics’ non-epilepsy CAMH diagnosis (13/18, 72.2%) relative to the control (7/18, 38.9%) arm,p= 0.092. The odds of identifying and recording a non-epilepsy CAMH diagnosis were 2.5 times higher in the intervention than control arms at the end of 3 months of follow-up [adj.OR 2.48; 95% CI (1.31–4.68);p= 0.005].Conclusion.In this setting, mhGAP CAMH training of PHC providers increases PHC clinics’ identification and reporting of non-epilepsy CAMH cases but this increase did not reach statistical significance.

scholarly journals Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial

Trials ◽  
2013 ◽  
Vol 14 (1) ◽  
pp. 348 ◽  
Author(s):  
Inmaculada Lupiáñez-Pérez ◽  
Juan Morilla-Herrera ◽  
Leovigildo Ginel-Mendoza ◽  
Francisco Martín-Santos ◽  
Francisco Navarro-Moya ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Primary Health Care ◽  
Olive Oil ◽  
Study Protocol ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Primary Health ◽  
Care Study

scholarly journals Long-term hospital-based secondary prevention of coronary artery disease: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Anete Kaldal ◽  
Serena Tonstad ◽  
Jarle Jortveit
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Ldl Cholesterol ◽  
Controlled Trial ◽  
Composite Endpoint ◽  
Free Survival ◽  
Randomized Controlled ◽  
Primary Health

Abstract Background and aims Despite established guidelines on secondary prevention of cardiovascular disease, practical implementation of treatment targets is deficient even in high-income countries. This study compared long-term hospital-based treatment with follow-up at primary health care regarding new cardiovascular events and achievement of treatment targets. Methods This randomized controlled trial at Sørlandet Hospital, Norway 2007–2021 included patients hospitalized due to myocardial infarction (n = 760) or after scheduled percutaneous coronary intervention (PCI) (n = 677) or coronary artery bypass grafting (n = 103). Patients were randomized to hospital-based secondary preventive care with consultations 2 weeks, 3 months, 6 months and 1 year after the index event and annually for up to 5 years, or follow-up at primary health care. Final data was collected after 10 years and hazard ratios were calculated using Cox regression analyses. Results Composite endpoint-free survival due to a lower rate of PCI improved in patients with hospital-based follow-up (n = 788) compared to patients followed-up at primary health care (n = 752) (HR 0.80, 95% CI 0.66–0.96; p = 0.02) but all-cause mortality was not reduced (HR 0.96, 95% CI 0.59–1.56; p = 0.86). At 1 year, LDL-cholesterol (2.1 [SD 0.7] versus 2.3 [SD 0.8] mmol/l; p < 0.001) and systolic blood pressure (132 [SD 16] versus 142 [SD 20] mm/Hg; p < 0.001) were lower in the hospital-based group, and the differences remained significant during the first 5 years. Other secondary preventive measures (smoking cessation, physical activity, body weight, glucose control, drug adherence) did not differ. Conclusions Long-term hospital-based secondary preventive follow-up improved composite endpoint-free survival, but not mortality. Substantial risk factors remained unaddressed. The beneficial effects on blood pressure and LDL-cholesterol disappeared after annual consultations ceased. Trial registration: The study is registered in ClinicalTrials.gov (NCT00679237) May 16, 2008.

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