Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil

Abstract Background The wide scale and severity of consequences of tobacco use, benefits derived from cessation, low rates of intervention by healthcare professionals, and new opportunities stemming from novel communications technologies are the main factors motivating this project. Thus, the purpose of this study is to assess the effectiveness of an intervention that helps people cease smoking and increase their nicotine abstinence rates in the long term via a chat-bot, compared to usual practice, utilizing a chemical validation at 6 months. Methods Design: Randomized, controlled, multicentric, pragmatic clinical trial, with a 6-month follow-up. Setting: Healthcare centers in the public healthcare system of the Community of Madrid (Madrid Regional Health Service). Participants: Smokers > 18 years of age who attend a healthcare center and accept help to quit smoking in the following month. N = 460 smokers (230 per arm) who will be recruited prior to randomization. Intervention group: use of a chat-bot with evidence-based contents to help quit smoking. Control group: Usual treatment (according to the protocol for tobacco cessation by the Madrid Regional Health Service Main variable: Continuous nicotine withdrawal with chemical validation (carbon monoxide in exhaled air). Intention-to-treat analysis. Difference between groups in continuous abstinence rates at 6 months with their corresponding 95% confidence interval. A logistic regression model will be built to adjust for confounding factors. Results: First expected results in January 2020. Discussion Providing science-based evidence on the effectiveness of clinical interventions via information technologies, without the physical presence of a professional, is essential. In addition to being more efficient, the characteristics of these interventions can improve effectiveness, accessibility, and adherence to treatment. From an ethics perspective, this new type of intervention must be backed by scientific evidence to circumvent pressures from the market or particular interests, improve patient safety, and follow the standards of correct practices for clinical interventions. Trial registration ClinicalTrials.gov, reference number NCT 03445507.

Download Full-text

FP02.01 Patient Responses to Passive Enrollment into a Large, Pragmatic Clinical Trial: A Qualitative Content Analysis

Journal of Thoracic Oncology ◽

10.1016/j.jtho.2021.01.073 ◽

2021 ◽

Vol 16 (3) ◽

pp. S188-S189

Author(s):

E. Rozema ◽

B. Creekmur ◽

V. Musigdilok ◽

M. Gould

Keyword(s):

Clinical Trial ◽

Content Analysis ◽

Qualitative Content Analysis ◽

Pragmatic Clinical Trial ◽

Patient Responses

Download Full-text

Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study

Contemporary Clinical Trials Communications ◽

10.1016/j.conctc.2021.100805 ◽

2021 ◽

pp. 100805

Author(s):

Katsuhisa Yamada ◽

Maeda Kenichiro ◽

Yoichi M. Ito ◽

Fujio Inage ◽

Toshiyuki Isoe ◽

...

Keyword(s):

Clinical Trial ◽

Pilot Study ◽

Lumbar Disc Herniation ◽

Disc Herniation ◽

Study Protocol ◽

Lumbar Disc

Download Full-text

First-in-human phase I clinical trial of a combined immune modulatory approach using TetMYB vaccine and Anti-PD-1 antibody in patients with advanced solid cancer including colorectal or adenoid cystic carcinoma: The MYPHISMO study protocol (NCT03287427)

Contemporary Clinical Trials Communications ◽

10.1016/j.conctc.2019.100409 ◽

2019 ◽

Vol 16 ◽

pp. 100409

Author(s):

Toan Pham ◽

Lloyd Pereira ◽

Sara Roth ◽

Laura Galletta ◽

Emma Link ◽

...

Keyword(s):

Clinical Trial ◽

Phase I ◽

Adenoid Cystic Carcinoma ◽

Study Protocol ◽

Phase I Clinical Trial ◽

Solid Cancer ◽

Adenoid Cystic

Download Full-text

Occupational therapy and psychosis: POINTER feasibility study for a pragmatic clinical trial

British Journal of Occupational Therapy ◽

10.1177/03080226211000257 ◽

2021 ◽

pp. 030802262110002

Author(s):

Joanne Inman ◽

Katrina Bannigan ◽

Jacqueline Akhurst

Keyword(s):

Clinical Trial ◽

Occupational Therapy ◽

Everyday Life ◽

Short Form ◽

Outcome Measurement ◽

Performance Measure ◽

Drop Out ◽

Secondary Outcome ◽

Occupational Performance ◽

Pragmatic Clinical Trial

Introduction The dearth of clinical trials of individualised occupational therapy with people with a diagnosis of psychosis limits the evidence base globally for occupational therapy practice. This study evaluated the feasibility of conducting a pragmatic clinical trial. Method Mixed methods design using a pragmatic perspective; two-centre, one-group pretest-posttest study, at six months. POINTER Occupational Intervention Specification captured routine individualised occupational therapy. Process evaluation included recruitment, retention, intervention delivery, fidelity, adherence and outcome measurement. The primary outcome was participation in activities of everyday life, measured by Time Use Survey, Participation Scale and Utrecht Scale for Evaluation of Rehabilitation-Participation. The Canadian Occupational Performance Measure measured self-reported experience of and satisfaction with occupational performance. The Short Form-36v2 Health Survey measured health-related quality of life, a secondary outcome. Participants’ experiences were explored using a questionnaire. Intervention providers’ perspectives were investigated via the POINTER occupational intervention log and focus groups. Results Recruitment was (20/36) and drop-out 20% (4/20). Fidelity was 77%, and adherence was good; POINTER had validity and utility. Outcome measurement was acceptable to participants, indicating increased participation in activities of everyday life. Conclusion A larger clinical trial is merited; recruitment processes need further exploration, and outcome measurement needs refining.

Download Full-text

Telerehabilitation Intervention in Patients with COVID-19 after Hospital Discharge to Improve Functional Capacity and Quality of Life. Study Protocol for a Multicenter Randomized Clinical Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18062924 ◽

2021 ◽

Vol 18 (6) ◽

pp. 2924

Author(s):

José-Manuel Pastora-Bernal ◽

María-José Estebanez-Pérez ◽

Guadalupe Molina-Torres ◽

Francisco-José García-López ◽

Raquel Sobrino-Sánchez ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Hospital Discharge ◽

Study Protocol ◽

Functional Capacity ◽

Treatment Method ◽

Current Evidence ◽

Current Standard

COVID-19 can cause important sequels in the respiratory system and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Physiotherapy interventions acquire a fundamental role in the recovery of the functions and the quality of life. Regarding the recovery phases after hospital discharge, the current evidence available is very preliminary. Telerehabilitation is presented as a promising complementary treatment method to standard physiotherapy. The main objective of this research is to evaluate the effectiveness of a personalized telerehabilitation intervention after discharge from hospital for the improvement of functional capacity and quality of life compared to a program of health education and/or care in a rehabilitation center. As secondary objectives, to identify the satisfaction and perception of patients with the telerehabilitation intervention and the presence of barriers to its implementation, as well as to evaluate the cost-effectiveness from the perspective of the health system. This study protocol will be carried out through a single blind multicenter randomized clinical trial in the south of Spain. We hypothesize that the implementation of a telerehabilitation program presents results not inferior to those obtained with the current standard intervention. If the hypothesis is confirmed, it would be an opportunity to define new policies and interventions to address this disease and its consequences. Trial registration NCT04742946.

Download Full-text