Faculty Opinions recommendation of Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM).

BACKGROUND Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE The aim of this study is to compare the effects and costs of the innovative <i>Smartphone Cardiac Rehabilitation, Assisted self-Management</i> (SCRAM) intervention with usual care CR. METHODS In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15022

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

10.21203/rs.2.19032/v2 ◽

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

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Effectiveness of non-medical health worker-led counselling on psychological distress: a randomized controlled trial in rural Nepal

Global Mental Health ◽

10.1017/gmh.2019.15 ◽

2019 ◽

Vol 6 ◽

Cited By ~ 1

Author(s):

N. Markkula ◽

V. Lehti ◽

P. Adhikari ◽

S. Peña ◽

J. Heliste ◽

...

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Psychological Distress ◽

Controlled Trial ◽

Randomized Controlled ◽

Primary Health ◽

Percentage Difference ◽

Psychosocial Counselling ◽

Rural Nepal ◽

To Receive

Background. An essential strategy to increase coverage of psychosocial treatments globally is task shifting to non-medical counsellors, but evidence on its effectiveness is still scarce. This study evaluates the effectiveness of lay psychosocial counselling among persons with psychological distress in a primary health care setting in rural Nepal. Methods. A parallel randomized controlled trial in Dang, rural Nepal (NCT03544450). Persons aged 16 and older attending primary care and with a General Health Questionnaire (GHQ-12) score of 6 or more were randomized (1:1) to receive either non-medical psychosocial counselling (PSY) or enhanced usual care (EUC). PSY was provided by lay persons with a 6-month training and consisted of 5-weekly counselling sessions of 35–60 min with a culturally adapted solution-focused approach. EUC was provided by trained primary health workers. Participants were followed up at 1 (T1) and 6 months (T2). The primary outcome, response to treatment, was the reduction of minimum 50% in the Beck Depression Inventory (BDI) score. Results. A total of 141 participants, predominantly socially disadvantaged women, were randomized to receive PSY and 146 to EUC. In the PSY, 123 participants and 134 in the EUC were analysed. In PSY, 101 participants (81.4%) had a response compared with 57 participants (42.5%) in EUC [percentage difference 39.4% (95% CI 28.4–50.4)]. The difference in BDI scores at T2 between PSY and EUC was −7.43 (95% CI −9.71 to −5.14). Conclusions. Non-medical (lay) psychosocial counselling appears effective in reducing depressive symptoms, and its inclusion in mental health care should be considered in low-resource settings.

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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

Global Mental Health ◽

10.1017/gmh.2018.18 ◽

2018 ◽

Vol 5 ◽

Cited By ~ 3

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.

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