Tag: Prevention

Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial

Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation. Our research was published in the journal JMIR Mental Health.

We used a 2-arm, single-blinded, parallel-group randomized controlled trial design. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date.

556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed.

We concluded that the Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.

DOI: https://doi.org/10.2196/22833

Development of a questionnaire to evaluate patients’ awareness of CVD risk in England’s NHS Health Check Programme

Cardiovascular disease (CVD) is a major cause of disability and premature mortality worldwide. In England, it accounts for a third of deaths and costs the National Health Service (NHS) and the UK economy £30 billion annually.

The National Health Service (NHS) Health Check is a CVD risk assessment and management programme in England aiming to increase CVD risk awareness among people at increased risk of CVD. There was previously no tool to assess the effectiveness of the programme in communicating CVD risk to patients. In research published in the journal BMJ Open, we describe how we developed a questionnaire examining patients’ CVD risk awareness for use in health service research evaluations of the NHS Health Check programme.

We developed an 85-item questionnaire to determine patients’ views of their risk of CVD. The questionnaire was based on a review of the relevant literature. After review by an expert panel and focus group discussion, 22 items were dropped and 2 new items were added. The resulting 65-item questionnaire with satisfactory content validity (content validity indices≥0.80) and face validity was tested on 110 NHS Health Check attendees.

Following analyses of data, we reduced the questionnaire from 65 to 26 items. The 26-item questionnaire constitutes four scales: Knowledge of CVD Risk and Prevention, Perceived Risk of Heart Attack/Stroke, Perceived Benefits and Intention to Change Behaviour and Healthy Eating Intentions. Perceived Risk (Cronbach’s α=0.85) and Perceived Benefits and Intention to Change Behaviour (Cronbach’s α=0.82) have satisfactory reliability (Cronbach’s α≥0.70). Healthy Eating Intentions (Cronbach’s α=0.56) is below minimum threshold for reliability but acceptable for a three-item scale.

This is the first study that describes the development of a short, validated questionnaire with satisfactory content and face validity and reliability examining CVD risk awareness among the NHS Health Check attendees. The ABCD Risk Questionnaire may be used for evaluating the accuracy of perceived CVD risk, general knowledge of CVD and intention to change behaviour regarding diet and exercise among NHS Health Check attendees.

Agreement between perceived and predicted CVD risk suggests that the tool performs well in assessing perceived CVD risk. As the questionnaire was developed using both an expert panel and a patient focus group, it ought to be relatively easy to understand for both patients and clinicians. If NHS Health Check recommendations change over time, it may need to be updated. The resulting questionnaire, with its satisfactory reliability and validity, may be used in assessing patients’ awareness of CVD risk among NHS Health Check attendees.

DOI: http://dx.doi.org/10.1136/bmjopen-2016-014413

Clinical impact of lifestyle interventions for the prevention of type 2 diabetes

In a study published in the journal BMJ Open, we reviewed the clinical outcomes of combined diet and physical activity interventions for people at high risk of type 2 diabetes. We looked at combined diet and physical activity interventions including ≥2 interactions with a healthcare professional, and ≥12 months follow-up. Our primary outcome measures included glycaemia, diabetes incidence. Secondary outcomes included behaviour change, measures of adiposity, vascular disease and mortality.

We identified 19 recent reviews for inclusion in our study. Most reviews reported that interventions were associated with net reductions in diabetes incidence, measures of glycaemia and adiposity. Small effect sizes and potentially transient effect were reported in some studies, and some reviewers noted that durability of intervention impact was potentially sensitive to duration of intervention and adherence to behaviour change. Behaviour change, vascular disease and mortality outcome data were infrequently reported, and evidence of the impact of intervention on these outcomes was minimal. Evidence for age effect was mixed, and sex and ethnicity effect were little considered.

We concluded that relatively long-duration lifestyle interventions can limit or delay progression to diabetes under trial conditions. However, outcomes from more time-limited interventions, and those applied in routine clinical settings, are more variable, in keeping with the findings of recent pragmatic trials. There is little evidence of intervention impact on vascular outcomes or mortality end points in any context. Hence, ‘real-world’ implementation of lifestyle interventions for diabetes prevention may be expected to lead to modest outcomes.