Exploring motivation and confidence in taking prescribed medicines in coexisting diseases: a qualitative study

Aims and objectives: To explore the motivation and confidence of people with coexisting diabetes, chronic kidney disease (CKD) and hypertension to take their medicines as prescribed. Background: These comorbidities are major contributors to disease burden globally. Self-management of individuals with these coexisting diseases is much more complicated than that of those with single diseases and is critical for improved health outcomes. Design: Motivational interviewing telephone calls were made with participants with coexisting diabetes, CKD and hypertension. Methods: Patients aged ≥18 years with diabetes, CKD and systolic hypertension were recruited from outpatient clinics of an Australian metropolitan hospital between 2008-2009. An average of four motivational interviewing telephone calls was made with participants (n = 39) in the intervention arm of a randomised controlled trial. Data were thematically analysed using the modified Health Belief Model as a framework. Results: Participants' motivation and confidence in taking prescribed medicines was thwarted by complex medicine regimens and medical conditions. Participants wanted control over their health and developed various strategies to confront threats to health. The perceived barriers of taking recommended health action outweighed the benefits of taking medicines as prescribed and were primarily related to copious amounts of medicines. Conclusion: Taking multiple prescribed medicines in coexisting diabetes, CKD and hypertension is a perpetual vocation with major psychosocial effects. Participants were overwhelmed by the number of medicines that they were required to take. The quest for personal control of health, fear of the future and the role of stress and gender in chronic disease management have been highlighted. Participants require supportive emotional interventions to self-manage their multiple medicines on a daily basis. Relevance to clinical practice: Reducing the complexity of medicine regimens in coexisting diseases is paramount. Individualised psychosocial approaches that address the emotional needs of patients with regular follow-up and feedback are necessary for optimal chronic disease self-management. © 2013 John Wiley & Sons Ltd.

Teeth Tales: a community-based child oral health promotion trial with migrant families in Australia

OBJECTIVES: The Teeth Tales trial aimed to establish a model for child oral health promotion for culturally diverse communities in Australia. DESIGN: An exploratory trial implementing a community-based child oral health promotion intervention for Australian families from migrant backgrounds. Mixed method, longitudinal evaluation. SETTING: The intervention was based in Moreland, a culturally diverse locality in Melbourne, Australia. PARTICIPANTS: Families with 1-4-year-old children, self-identified as being from Iraqi, Lebanese or Pakistani backgrounds residing in Melbourne. Participants residing close to the intervention site were allocated to intervention. INTERVENTION: The intervention was conducted over 5 months and comprised community oral health education sessions led by peer educators and follow-up health messages. OUTCOME MEASURES: This paper reports on the intervention impacts, process evaluation and descriptive analysis of health, knowledge and behavioural changes 18 months after baseline data collection. RESULTS: Significant differences in the Debris Index (OR=0.44 (0.22 to 0.88)) and the Modified Gingival Index (OR=0.34 (0.19 to 0.61)) indicated increased tooth brushing and/or improved toothbrushing technique in the intervention group. An increased proportion of intervention parents, compared to those in the comparison group reported that they had been shown how to brush their child's teeth (OR=2.65 (1.49 to 4.69)). Process evaluation results highlighted the problems with recruitment and retention of the study sample (275 complete case families). The child dental screening encouraged involvement in the study, as did linking attendance with other community/cultural activities. CONCLUSIONS: The Teeth Tales intervention was promising in terms of improving oral hygiene and parent knowledge of tooth brushing technique. Adaptations to delivery of the intervention are required to increase uptake and likely impact. A future cluster randomised controlled trial would provide strongest evidence of effectiveness if appropriate to the community, cultural and economic context. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12611000532909).

Protocol for the Hall Technique study: A trial to measure clinical effectiveness and cost-effectiveness of stainless steel crowns for dental caries restoration in primary molars in young children

BACKGROUND: The Hall Technique (HT) is a carious primary molar treatment that does not require local analgesia, carious tissue removal or tooth preparation. The carious lesions in carefully selected teeth are sealed with a stainless steel crown (preformed metal crown). The study aims are to determine the clinical effectiveness, acceptability and cost-effectiveness of the HT for management of carious lesions in young dental patients. METHODS/DESIGN: Children, aged 3-7years, with a primary molar tooth with a carious lesion extending no further than the middle third of dentine, with no signs or symptoms of pulp inflammation or infection, and attending one of three community agencies are recruited. Target sample size is 220. A control tooth with an intra-coronal restoration is sourced from the same mouth. The primary outcome is the period of time free from further treatment. The assessments are scheduled at 6, 12 and 24months. In addition to the clinical assessment, acceptability of the HT will be assessed via questionnaires among patients and their primary carers at baseline, 6, 12 and 24months. Cost-outcome description and cost-effectiveness analysis from healthcare provider and societal perspective will be conducted. DISCUSSION: The clinical effectiveness, acceptability and cost-effectiveness of the HT in the community dental setting will be evaluated. The results of this study will determine the implementation of HT in the management of dental caries in young children.

Assessing randomised clinical trials of cognitive and exposure therapies for gambling disorders : a systematic review

Aims: Problem or pathological gambling is associated with significant disruption to the individual, family and community with a range of adverse outcomes, including legal, financial and mental health impairment. It occurs more frequently in younger populations, and comorbid conditions are common. Cognitive–behaviour therapy (CBT) is the most empirically established class of treatments for problematic gambling. This article reports on a systematic review and evaluation of randomised clinical trials (RCTs) concerning two core techniques of CBT: cognitive and behavioural (exposure-based) therapies. Methods: PsycINFO, MEDLINE and the Cochrane library were searched from database inception to December 2012. The CONsolidated Standards Of Reporting Trials (CONSORT) for non-pharmacological treatments was used to evaluate each study. Results: The initial search identified 104 references. After two screening phases, seven RCTs evaluating either cognitive (n = 3), exposure (n = 3) or both (n = 1) interventions remained. The studies were published between 1983 and 2003 and conducted across Australia, Canada, and Spain. On average, approximately 31% of CONSORT items were rated as ‘absent’ for each study and more than 52% rated as ‘present with some limitations’. For all studies, 70.83% of items rated as ‘absent’ were in the methods section. Conclusions: The findings from this review of randomised clinical trials involving cognitive and exposure-based treatments for gambling disorders show that the current evidence base is limited. Trials with low risk of bias are needed to be reported before recommendations are given on their effectiveness and clinicians can appraise their potential utility with confidence.

The PREPARE pilot RCT of home-based progressive resistance exercises for venous leg ulcers

OBJECTIVE: To establish the feasibility of conducting a home-based progressive resistance exercise programme to improve calf muscle pump function in community-based patients with venous leg ulcers. METHOD: Participants were randomised to receive a 12-week progressive resistance exercise programme using heel raises in addition to compression. The control was usual care in addition to compression. Randomisation was stratified by ulcer duration and ulcer size. Air plethysmography was used to determine changes in calf muscle pump function from baseline. Changes in ulcer parameters were measured using the SilhouetteMobile device. RESULTS: Forty participants were randomised. There were significantly greater improvements in ejection fraction of the calf muscle in the exercise group compared with the control (usual care) group (mean difference 18.5%, 95% CI 0.03 to 36.6%, p<0.05). Other parameters improved in the exercise group but the mean differences were not significant. Adherence with prescribed exercises was 81% and there was no significant difference in the numbers reporting adverse events. There were also no significant differences in ulcer healing parameters (change in area, percentage change in area, number healed at 12 weeks, time to healing). CONCLUSION: A community-based randomised trial of progressive resistance exercise is feasible. The prescribed exercises appeared to increase ejection fraction, but the effect of exercise on ulcer healing requires further investigation.

Clustering of adherence to personalised dietary recommendations and changes in healthy eating index within the Food4Me study

OBJECTIVE: To characterise clusters of individuals based on adherence to dietary recommendations and to determine whether changes in Healthy Eating Index (HEI) scores in response to a personalised nutrition (PN) intervention varied between clusters.

DESIGN: Food4Me study participants were clustered according to whether their baseline dietary intakes met European dietary recommendations. Changes in HEI scores between baseline and month 6 were compared between clusters and stratified by whether individuals received generalised or PN advice.

SETTING: Pan-European, Internet-based, 6-month randomised controlled trial.

SUBJECTS: Adults aged 18-79 years (n 1480).

RESULTS: Individuals in cluster 1 (C1) met all recommended intakes except for red meat, those in cluster 2 (C2) met two recommendations, and those in cluster 3 (C3) and cluster 4 (C4) met one recommendation each. C1 had higher intakes of white fish, beans and lentils and low-fat dairy products and lower percentage energy intake from SFA (P<0·05). C2 consumed less chips and pizza and fried foods than C3 and C4 (P<0·05). C1 were lighter, had lower BMI and waist circumference than C3 and were more physically active than C4 (P<0·05). More individuals in C4 were smokers and wanted to lose weight than in C1 (P<0·05). Individuals who received PN advice in C4 reported greater improvements in HEI compared with C3 and C1 (P<0·05).

CONCLUSIONS: The cluster where the fewest recommendations were met (C4) reported greater improvements in HEI following a 6-month trial of PN whereas there was no difference between clusters for those randomised to the Control, non-personalised dietary intervention.

Characteristics of European adults who dropped out from the Food4Me internet-based personalised nutrition intervention

OBJECTIVE: To characterise participants who dropped out of the Food4Me Proof-of-Principle study.

DESIGN: The Food4Me study was an Internet-based, 6-month, four-arm, randomised controlled trial. The control group received generalised dietary and lifestyle recommendations, whereas participants randomised to three different levels of personalised nutrition (PN) received advice based on dietary, phenotypic and/or genotypic data, respectively (with either more or less frequent feedback).

SETTING: Seven recruitment sites: UK, Ireland, The Netherlands, Germany, Spain, Poland and Greece.

SUBJECTS: Adults aged 18-79 years (n 1607).

RESULTS: A total of 337 (21 %) participants dropped out during the intervention. At baseline, dropouts had higher BMI (0·5 kg/m2; P<0·001). Attrition did not differ significantly between individuals receiving generalised dietary guidelines (Control) and those randomised to PN. Participants were more likely to drop out (OR; 95 % CI) if they received more frequent feedback (1·81; 1·36, 2·41; P<0·001), were female (1·38; 1·06, 1·78; P=0·015), less than 45 years old (2·57; 1·95, 3·39; P<0·001) and obese (2·25; 1·47, 3·43; P<0·001). Attrition was more likely in participants who reported an interest in losing weight (1·53; 1·19, 1·97; P<0·001) or skipping meals (1·75; 1·16, 2·65; P=0·008), and less likely if participants claimed to eat healthily frequently (0·62; 0·45, 0·86; P=0·003).

CONCLUSIONS: Attrition did not differ between participants receiving generalised or PN advice but more frequent feedback was related to attrition for those randomised to PN interventions. Better strategies are required to minimise dropouts among younger and obese individuals participating in PN interventions and more frequent feedback may be an unnecessary burden.

Development and evaluation of a computer-based, self-management tool for people recently diagnosed with type 2 diabetes

Aim. The purpose of this study was to develop and evaluate a computer-based, dietary, and physical activity self-management program for people recently diagnosed with type 2 diabetes. Methods. The computer-based program was developed in conjunction with the target group and evaluated in a 12-week randomised controlled trial (RCT). Participants were randomised to the intervention (computer-program) or control group (usual care). Primary outcomes were diabetes knowledge and goal setting (ADKnowl questionnaire, Diabetes Obstacles Questionnaire (DOQ)) measured at baseline and week 12. User feedback on the program was obtained via a questionnaire and focus groups. Results. Seventy participants completed the 12-week RCT (32 intervention, 38 control, mean age 59 (SD) years). After completion there was a significant between-group difference in the "knowledge and beliefs scale" of the DOQ. Two-thirds of the intervention group rated the program as either good or very good, 92% would recommend the program to others, and 96% agreed that the information within the program was clear and easy to understand. Conclusions. The computer-program resulted in a small but statistically significant improvement in diet-related knowledge and user satisfaction was high. With some further development, this computer-based educational tool may be a useful adjunct to diabetes self-management. This trial is registered with clinicaltrials.gov NCT number NCT00877851.

Interventions to reduce sedentary behaviour in 0-5-year-olds: A systematic review and meta-analysis of randomised controlled trials

Aim or objective To evaluate the effectiveness of behavioural interventions that report sedentary behaviour outcomes during early childhood. Design Systematic review and meta-analysis. Data sources Academic Search Complete, CINAHL Complete, Global Health, MEDLINE Complete, PsycINFO, SPORTDiscus with Full Text and EMBASE electronic databases were searched in March 2016. Eligibility criteria for selecting studies Inclusion criteria were: (1) published in a peer-reviewed English language journal; (2) sedentary behaviour outcomes reported; (3) randomised controlled trial (RCT) study design; and (4) participants were children with a mean age of =5.9 years and not yet attending primary/ elementary school at postintervention. Results 31 studies were included in the systematic review and 17 studies in the meta-analysis. The overall mean difference in screen time outcomes between groups was -17.12 (95% CI -28.82 to -5.42) min/day with a significant overall intervention effect (Z=2.87, p=0.004). The overall mean difference in sedentary time between groups was -18.91 (95% CI -33.31 to -4.51) min/day with a significant overall intervention effect (Z=2.57, p=0.01). Subgroup analyses suggest that for screen time, interventions of =6 months duration and those conducted in a community-based setting are most effective. For sedentary time, interventions targeting physical activity (and reporting changes in sedentary time) are more effective than those directly targeting sedentary time. Summary/conclusions Despite heterogeneity in study methods and results, overall interventions to reduce sedentary behaviour in early childhood show significant reductions, suggesting that this may be an opportune time to intervene.

A public health intervention to change knowledge, attitudes and behaviour regarding alcohol consumption in pregnancy

Aim. To evaluate the effectiveness of a public health intervention aimed at changing knowledge, attitudes and behaviour. Methods. A non-blinded parallel group randomised controlled trial of pregnant women over 18 years of age. Women were recruited in the second trimester and assigned to one of two treatment groups. Both groups completed an initial questionnaire assessing knowledge, attitudes, and practices relating to alcohol consumption during pregnancy. The intervention group then received a mocktail recipe booklet and participants were asked to share the information with their partner. The control group received standard antenatal care. A follow-up questionnaire was conducted four weeks post birth. Primary outcome measures were a knowledge score of the health risks associated with alcohol consumption during pregnancy and an attitude score toward drinking during pregnancy. Secondary outcome measures included whether or not the woman and her partner abstained from drinking. Ethical approval was granted by the Women’s and Children’s Health Network and the University of South Australia. Results. A total of 161 participants were recruited at baseline (intervention = 82, control = 79) and 96 participants completed the trial (intervention = 49, control = 47). The findings suggest that the mocktail booklet was effective at improving knowledge (p<0.001; effect size 0.80) and improving attitudes towards drinking during pregnancy (p=0.017; effect size 0.43) in the intervention group compared to the control group. Although women in the intervention group were 30% more likely to abstain from drinking than in the control group (RR=1.3, 95% CI 0.97 – 1.75), this result was not statistically significant (p=0.077). Conclusions. Knowledge regarding the effects of alcohol consumption as well as attitudes towards drinking significantly improved as a result of a mocktail recipe booklet. Improving knowledge and changing attitudes has the potential to change health behaviour. Therefore, this intervention may reduce the percentage of women who continue to drink alcohol while they are pregnant and improve outcomes for infants and children.