scholarly journals Telemonitoring patients with chronic diseases in primary care. Three and six-month follow-up results of a randomized controlled trial (TELBIL study)

2011 ◽  
Vol 11 (6) ◽  
Author(s):  
Iñaki Martín Lesende ◽  
Estibalitz Orruño Aguado ◽  
Carmen Cairo Rojas ◽  
Eva Reviriego Rodrigo ◽  
Juan Carlos Bayón Yusta ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Chronic Diseases ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals A Mobile Health Salt Reduction Intervention for People With Hypertension: Results of a Feasibility Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Sarah Payne Riches ◽  
Carmen Piernas ◽  
Paul Aveyard ◽  
James P Sheppard ◽  
Mike Rayner ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Salt Intake ◽  
Controlled Trial ◽  
Salt Content ◽  
Salt Reduction ◽  
Randomized Controlled ◽  
Secondary Outcomes

BACKGROUND A high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs. OBJECTIVE The aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention’s effectiveness. METHODS This feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated. RESULTS A total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors. CONCLUSIONS The intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962

scholarly journals Posttraumatic Stress Disorder Intervention for People with Severe Mental Illness in a Low-Income Country Primary Care Setting: A Randomized Feasibility Trial Protocol

2021 ◽  
Author(s):  
Lauren Ng ◽  
Eyerusalem Getachew Serba ◽  
Benyam W. Dubale ◽  
Abebaw Fekadu ◽  
Charlotte Hanlon
Keyword(s):  
Primary Care ◽  
Posttraumatic Stress Disorder ◽  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Intervention Delivery ◽  
Randomized Controlled

Abstract BackgroundIn this protocol, we outline a mixed-methods randomized feasibility trial of Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia. BREATHE Ethiopia is a culturally and contextually adapted intervention for PTSD in participants with severe mental illness. BREATHE Ethiopia maps onto the World Health Organization’s guidelines for posttraumatic stress disorder (PTSD) treatment in low- and middle-income country primary care settings. MethodsSpecifically, this study includes a non-randomized pre-pilot (n=5) and a randomized feasibility trial comparing BREATHE Ethiopia to Treatment as Usual (n=40) to assess trial procedures, acceptability and feasibility of intervention delivery, and investigate potential effectiveness and implementation. In a process evaluation we will collect data that will be critical for a future fully randomized controlled trial, including the numbers of participants who are eligible, who consent, who engage in treatment, and who complete the assessments, as well as the feasibility and acceptability of assessments and the intervention. Qualitative data on facilitators and barriers to intervention delivery and quantitative data on provider fidelity to the intervention and participant and provider satisfaction will also be collected. Quantitative assessments at baseline, post-treatment, one-month follow-up, and three-month follow-up will assess change in mental health symptoms and functional impairment and hypothesized intervention mechanisms, including knowledge about PTSD, stigma, trauma-related cognitions, and physiological arousal. DiscussionFindings from this study will inform a future fully-powered randomized controlled trial, and if found to be effective, the intervention has the potential to be integrated into mental healthcare scale-up efforts in other low-resource settings. Trial RegistrationRegistered with ClinicalTrials.gov (NCT04385498) first posted May 13th, 2020; https://www.clinicaltrials.gov/ct2/show/NCT04385498?term=ethiopia&cond=PTSD&draw=2&rank=1.

scholarly journals Short-term effects of enhanced treatment for depression in primary care: results from a randomized controlled trial

2005 ◽  
Vol 36 (1) ◽  
pp. 15-26 ◽  
Author(s):  
A. SMIT ◽  
H. KLUITER ◽  
H. J. CONRADI ◽  
K. VAN DER MEER ◽  
B. G. TIEMENS ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Modalities ◽  
Psychiatric Evaluation ◽  
Patient Acceptance ◽  
Short Term ◽  
Psychiatric Interview ◽  
Randomized Controlled

Background. Depression is a highly prevalent, often recurring or persistent disorder. The majority of patients are initially seen and treated in primary care. Effective treatments are available, but possibilities for providing adequate follow-up care are often limited in this setting. This study assesses the effectiveness of primary-care-based enhanced treatment modalities on short-term patient outcomes.Method. In a randomized controlled trial we evaluated a psycho-educational self-management intervention. We included 267 adult patients meeting criteria for a DSM-IV diagnosis of major depressive disorder, assessed by a structured psychiatric interview. Patients were randomly assigned to: the Depression Recurrence Prevention (DRP) program (n=112); a combination of the DRP program with psychiatric consultation (PC+DRP, n=39); a combination with brief cognitive behavior therapy (CBT+DRP, n=44); and care as usual (CAU, n=72). Follow-up assessments were made at 3 months (response 90%) and 6 months (85%).Results. Patient acceptance of enhanced care was good. The mean duration of the index episode was 11 weeks (S.D.=9·78) and similar in CAU and enhanced care. Recovery rate after 6 months was 67% overall; 17% of all participants remained depressed for the entire 6-month period.Conclusion. Enhanced care did not result in better short-term outcomes. We found no evidence that the DRP program was more effective than CAU and no indications for added beneficial effects of either the psychiatric evaluation or the CBT treatment to the basic format of the DRP program. Observed depression treatment rates in CAU were high.

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