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Background: Early language delay is exacerbated by social disadvantage. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. Methods used to achieve successful health outcomes in socially disadvantaged clinical populations may need enhancing. Aims: To compare the impact of standard parent‐based intervention (PBI) to enhanced PBI for young children with speech, language and communication needs (SCLN) and their families living in more socially disadvantaged populations. Methods and Procedures: A multicentre clustered blind randomised controlled trial was used to compare the effect of parent‐based group interventions to improve early language development with children (mean age 27.5 months) from more socially disadvantaged populations with an expressive vocabulary of 40 or less single words. Intervention sessions were delivered by a speech and language therapist, over a 20‐week period. Participants received one of two interventions: (1) Standard Care – indirect group PBI – (PBI) (2) Enhanced Care: indirect group enhanced PBI – (EPBI). Both standardised and non‐standardised measures were used as outcomes. Parent engagement in the intervention was captured through analysis of attendance and the Parent Activation Measure – Speech & Language Therapy (PAM‐SLT) (Insignia Health, 2014). The PAM measures a person's knowledge, skills and confidence to manage their own health and well‐being (NHS England, 2018). In this study, activation referred to parents' knowledge, skills and confidence to manage their child's language development. Outcomes and Results: One hundred fifty‐five participants were randomised at baseline. Children in both groups made significant improvements in the outcome on MacArthur‐Bates Communicative Development Inventories Sentence Length, from pre‐intervention to post‐intervention and 6 months post‐intervention (p < 0.05). Changes in vocabulary and expressive language skills were more equivocal, showing wide variation in confidence intervals for both groups. Where parents attended at least one intervention session almost all effect sizes were in favour of the EPBI intervention. Parents' activation levels significantly increased for both groups (EPBI p < 0.001, PBI p = 0.003), with a moderate effect size in favour of EPBI (Hedges' G 0.37, confidence interval –0.02 to 0.76), although wide variation was found. Conclusions and Implications: This trial provides some evidence of facilitating the language development of children with SLCN from more socially disadvantaged areas through supporting caregivers. However, we found variation in outcomes; some children made excellent progress, whilst others did not. Further exploration of parent engagement and its relationship to child language outcomes will be valuable to understanding more about mechanisms of change in interventions that involve parents. WHAT THIS PAPER ADDS: What is already known on the subject: Speech, language and communication needs (SLCN) have a knock‐on effect on emotional well‐being, school readiness, literacy and school attainment, putting children at increased risk of long‐term consequences such as poor literacy, mental health problems and unemployment. In disadvantaged areas, the prevalence of language difficulties is higher than elsewhere. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. What this paper adds to existing knowledge: Children with SLCN from more socially disadvantaged areas can make improvements in their language development through parent intervention, although wide individual variation was found. There was some evidence that children achieve better outcomes with EPBI, which employed an interagency collaborative approach. Parent's engagement (activation levels) increased significantly over time with intervention, with the increase twice as big for EPBI. What are the potential or actual clinical implications of this work?: This trial provides some evidence that it is possible to facilitate the language development of children from more socially disadvantaged areas through supporting their caregivers. Further research would be useful to determine whether increases in parent engagement are related to adherence to intervention and change in child outcomes. [ABSTRACT FROM AUTHOR]

Background: Very young children from lower socioeconomic status (SES) backgrounds often show poorer language development. Whilst there have been attempts to provide early intervention programmes, these sometimes miss the most disadvantaged groups. Aims: This report presents preliminary feasibility and effectiveness data for a novel language intervention designed for parents of toddlers in the United Kingdom. Methods and Procedures: In total, 43 UK families of 2–4‐year‐olds were recruited to the study, half of whom completed an 8‐week course (Tots Talking) focussed on parent interaction, and half of whom acted as wait‐list controls. Results and Outcomes: Results suggest that such programmes are feasible for families with 86% staying in the intervention. In addition, greater changes in underlying communication skills such as joint attention and gesture were evident compared to wait‐list controls. Conclusions and Implications: We conclude that pre‐verbal skills may be more important to measure as initial outcomes than language or vocabulary change in this population. What This Paper Adds: What is already known on the subject: Children from lower socioeconomic status (SES) backgrounds are at higher risk of communication difficulties and there is a need for community intervention programmes for very young children. What this study adds: This study suggests that such programmes can be feasible and effective, but that very early/basic communicative skills (such as joint attention) may be boosted first rather than language or vocabulary. What are the clinical implications of this work?: Children's centres and other community services could feasibly run short parent facing courses emphasising contingent communication in low SES families and other diverse groups. These may be more successful run with younger preschoolers. Joint attention may be a better focus of intervention before expecting vocabulary or language change. Community health professionals may find this information useful in referring and supporting families in need. [ABSTRACT FROM AUTHOR]

Background Although most people are aware of government guidelines for alcohol consumption, few have accurate knowledge of these and fewer still use these guidelines to monitor their drinking. Most people also lack accurate knowledge of the alcohol content of the drinks they consume. The aim of the study reported here was to examine whether or not personalized feedback on alcohol consumption based on performance in a drink-pouring task and self-reported alcohol intake would improve university students' knowledge of alcohol consumption guidelines and reduce their alcohol intake. Methods A quasi-randomized control trial with a 2-month follow-up was conducted with 200 students aged 18 to 37 in the south of England. Participants were allocated to a 'pour + feedback' group that completed a drink-pouring task and received personalized feedback, a 'pour only' group that completed the drink-pouring task but did not receive feedback, and a control group. Results At follow-up, participants in the 'pour + feedback' group had significantly better knowledge of government guidelines, and significantly lower weekly alcohol intake when compared to the 'control' and 'pour only' groups. Conclusions Further refinement of the drink-pouring intervention and feedback is reported in this paper, and assessment of their impact in various populations may lead to better understanding of which elements of personalized feedback have the greatest influence on young people's alcohol use. [ABSTRACT FROM AUTHOR]

Objectives: The FiCTION trial compared co‐primary outcomes (dental pain and/or infection) and secondary outcomes (child oral health‐related quality of life [COHRQOL], child dental anxiety, cost‐effectiveness, caries development/progression and acceptability) across three treatment strategies (Conventional with Prevention [C + P]; Biological with Prevention [B + P]; Prevention Alone [PA]) for managing caries in children in primary care. COHRQOL and child dental anxiety experiences are reported upon here. Methods: A multi‐centre, 3‐arm, parallel‐group, unblinded patient‐randomized controlled trial of 3‐ to 7‐year‐olds treated under NHS contracts was conducted in 72 general dental practices in England, Wales and Scotland. Child participants (with at least one primary molar with dentinal caries) were randomized (1:1:1) to one of three treatment arms with the intention of being managed according to allocated arm for 3 years (minimum 23 months). Randomization was via a centrally administered system using random permuted blocks of variable length. At baseline and final visit, accompanying parents/caregivers completed a parental questionnaire including COHRQOL (16 item P‐CPQ‐16), and at every visit, child‐ and parental‐questionnaire‐based data were collected for child‐based dental trait and state anxiety. Statistical analyses were conducted on complete cases from the modified intention‐to‐treat (mITT) analysis set. Results: A total of 1144 children were randomized (C + P: 386; B + P: 381; PA: 377). The mITT analysis set included the 1058 children who attended at least one study visit (C + P: 352; B + P: 352; PA: 354). Median follow‐up was 33.8 months (IQR: 23.8, 36.7). The P‐CPQ‐16 overall score could be calculated after simple imputation at both baseline and final visit for 560 children (C + P: 189; B + P: 189; PA: 182). There was no evidence of a difference in the estimated adjusted mean P‐CPQ‐16 at the final visit which was, on average, 0.3 points higher (97.5% CI: −1.1 to 1.6) in B + P than C + P and 0.2 points higher, on average, (97.5% CI: −1.2 to 1.5) in PA than for C + P. Child dental trait anxiety and child dental state anxiety, measured at every treatment visit, showed no evidence of any statistically or clinically significant difference between arms in adjusted mean scores averaged over all follow‐up visits. Conclusions: The differences noted in COHRQOL and child‐based dental trait and dental state anxiety measures across three treatment strategies for managing dental caries in primary teeth were small, and not considered to be clinically meaningful. The findings highlight the importance of including all three strategies in a clinician's armamentarium, to manage childhood caries throughout the young child's life and achieve positive experiences of dental care. [ABSTRACT FROM AUTHOR]

Background: Diagnosis of attention deficit hyperactivity disorder (ADHD) relies on subjective methods which can lead to diagnostic uncertainty and delay. This trial evaluated the impact of providing a computerised test of attention and activity (QbTest) report on the speed and accuracy of diagnostic decision‐making in children with suspected ADHD. Methods: Randomised, parallel, single‐blind controlled trial in mental health and community paediatric clinics in England. Participants were 6–17 years‐old and referred for ADHD diagnostic assessment; all underwent assessment‐as‐usual, plus QbTest. Participants and their clinician were randomised to either receive the QbTest report immediately (QbOpen group) or the report was withheld (QbBlind group). The primary outcome was number of consultations until a diagnostic decision confirming/excluding ADHD within 6‐months from baseline. Health economic cost‐effectiveness and cost utility analysis was conducted. Assessing QbTest Utility in ADHD: A Randomised Controlled Trial was registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02209116). Results: One hundred and thirty‐two participants were randomised to QbOpen group (123 analysed) and 135 to QbBlind group (127 analysed). Clinicians with access to the QbTest report (QbOpen) were more likely to reach a diagnostic decision about ADHD (hazard ratio 1.44, 95% CI 1.04–2.01). At 6‐months, 76% of those with a QbTest report had received a diagnostic decision, compared with 50% without. QbTest reduced appointment length by 15% (time ratio 0.85, 95% CI 0.77–0.93), increased clinicians' confidence in their diagnostic decisions (odds ratio 1.77, 95% CI 1.09–2.89) and doubled the likelihood of excluding ADHD. There was no difference in diagnostic accuracy. Health economic analysis showed a position of strict dominance; however, cost savings were small suggesting that the impact of providing the QbTest report within this trial can best be viewed as 'cost neutral'. Conclusions: QbTest may increase the efficiency of ADHD assessment pathway allowing greater patient throughput with clinicians reaching diagnostic decisions faster without compromising diagnostic accuracy. [ABSTRACT FROM AUTHOR]

Abstract: Aims: To assess the cost‐effectiveness of a two‐component intervention designed to increase attendance at the NHS Stop Smoking Services (SSSs) in England. Design: Cost‐effectiveness analysis alongside a randomized controlled trial (Start2quit). Setting: NHS SSS and general practices in England. Participants: The study comprised 4384 smokers aged 16 years or more identified from medical records in 99 participating practices, who were motivated to quit and had not attended the SSS in the previous 12 months. Intervention and comparator: Intervention was a personalized and tailored letter sent from the general practitioner (GP) and a personal invitation and appointment to attend a taster session providing information about SSS. Control was a standard generic letter from the GP advertising SSS and asking smokers to contact the service to make an appointment. Measurements: Costs measured from an NHS/personal social services perspective, estimated health gains in quality‐adjusted life‐years (QALYs) measured with EQ‐5D and incremental cost per QALY gained during both 6 months and a life‐time horizon. Findings: During the trial period, the adjusted mean difference in costs was £92 [95% confidence interval (CI) = –£32 to –£216) and the adjusted mean difference in QALY gains was 0.002 (95% CI = –0.001 to 0.004). This generates an incremental cost per QALY gained of £59 401. The probability that the tailored letter and taster session is more cost‐effective than the generic letter at 6 months is never above 50%. In contrast, the discounted life‐time health‐care cost was lower in the intervention group, while the life‐time QALY gains were significantly higher. The probability that the intervention is more cost‐effective is more than 83% using a £20 000–30 000 per QALY‐gained decision‐making threshold. Conclusions: An intervention designed to increase attendance at the NHS Stop Smoking Services (tailored letter and taster session in the services) appears less likely to be cost‐effective than a generic letter in the short term, but is likely to become more cost‐effective than the generic letter during the long term. [ABSTRACT FROM AUTHOR]

Abstract: Background: Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post‐stroke pneumonia, which causes 30% of stroke‐related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post‐stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. Aims: This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow‐strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post‐stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full‐scale trial. Methods & Procedures: Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration‐Aspiration Scale (PAS) and patient‐reported outcomes (Swallow Related Quality of Life—SWAL‐QOL). Outcomes & Results: Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual‐care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. Conclusions & Implications: The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically meaningful outcome improvements, justifying progression to a fully powered study. It also showed clinically meaningful treatment trends for the Ampcare ESP intervention. [ABSTRACT FROM AUTHOR]

Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug-related death soon after release from prison. The NALoxone InVEstigation (N-ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England. Design. Parallel-group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre-randomization, release due within 3 months and more than 6 months since previous N-ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single 'rescue' injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self-questionnaires (RPSQs: 207), NOR-carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70-74%]; 218 RPSQs were received; NOR-carriage (95% CI = 63-79%) and overdose presence (95% CI = 75-84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one-third of NOR administrations were to the ex-prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take-home emergency naloxone prior to prison release may be a life-saving interim measure to prevent heroin overdose deaths among ex-prisoners and the wider population. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Method Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER+ and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Results Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes ( P of interaction = .019). Conclusion There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. [ABSTRACT FROM AUTHOR]

Background While practitioners are increasingly asked to be mindful of the evidence base of intervention programmes, evidence from rigorous trials for the effectiveness of interventions that promote oral language abilities in the early years is sparse. Aims To evaluate the effectiveness of a language intervention programme for children identified as having poor oral language skills in preschool classes. Methods & Procedures A randomized controlled trial was carried out in 13 UK nursery schools. In each nursery, eight children ( N = 104, mean age = 3 years 11 months) with the poorest performance on standardized language measures were selected to take part. All but one child were randomly allocated to either an intervention ( N = 52) or a waiting control group ( N = 51). The intervention group received a 15-week oral language programme in addition to their standard nursery curriculum. The programme was delivered by trained teaching assistants and aimed to foster vocabulary knowledge, narrative and listening skills. Outcomes & Results Initial results revealed significant differences between the intervention and control group on measures of taught vocabulary. No group differences were found on any standardized language measure; however, there were gains of moderate effect size in listening comprehension. Conclusions & Implications The study suggests that an intervention, of moderate duration and intensity, for small groups of preschool children successfully builds vocabulary knowledge, but does not generalize to non-taught areas of language. The findings strike a note of caution about implementing language interventions of moderate duration in preschool settings. The findings also highlight the importance of including a control group in intervention studies. [ABSTRACT FROM AUTHOR]

Aim: The purpose of this study was to replicate and extend a pilot evaluation of the effectiveness of school‐based humanistic counselling for psychological distress in young people. Method: Data were available on 32 young people who were randomised to either school‐based humanistic counselling or waiting list conditions for one school term. The primary outcome measure was of psychological distress using the Young Person's CORE (YP‐CORE), at six and 12 weeks post‐assessment. Secondary measures at these time‐points were of psychological difficulties, self‐esteem, levels of depression, and attainment of personal goals; with longitudinal evaluation of outcomes at six months post‐assessment. Results: On the primary outcome measure, participants who received counselling were significantly less distressed at six weeks than those in the waiting list group but not at 12 weeks, with effect sizes (Cohen's d) of 0.59 and 0.39 respectively. Reductions in psychological distress were maintained at follow‐up. Discussion: Although the present findings, in isolation, are equivocal, they contribute to a body of evidence that supports the effectiveness of school‐based humanistic counselling. However, the principal lesson learnt from this study was the need for rigorous training of researchers, counsellors and pastoral care teachers to ensure adherence to protocols. [ABSTRACT FROM AUTHOR]

Aims Most people who quit smoking for a short term will return to smoking again in 12 months. We tested whether self-help booklets can reduce relapse in short-term quitters after receiving behavioural and pharmacological cessation treatment. Design A parallel-arm, pragmatic individually randomized controlled trial. Setting Smoking cessation clinics in England. Participants People who stopped smoking for 4 weeks after receiving cessation treatment in stop smoking clinics. Intervention Participants in the experimental group (n = 703) were mailed eight booklets, each of which taught readers how to resist urges to smoke. Participants in the control group (n = 704) received a leaflet currently used in practice. Measurements The primary outcome was prolonged, carbon monoxide-verified abstinence from months 4 to 12. The secondary outcomes included 7-day self#x02010;reported abstinence at 3 and 12 months. Mixed-effects logistic regression was used to estimate treatment effects and to investigate possible effect modifying variables. Findings There were no statistically significant differences between the groups in prolonged abstinence from months 4 to 12 (36.9% versus 38.6%; odds ratio 0.93, 95% confidence interval 0.75-1.16; P = 0.524). In addition, there were no significant differences between the groups in any secondary outcomes. However, people who reported knowing risky situations for relapse and using strategies to handle urges to smoke were less likely to relapse. Conclusions In people who stop smoking successfully with behavioural support, a comprehensive self-help educational programme to teach people skills to identify and respond to high-risk situations for return to smoking did not reduce relapse. [ABSTRACT FROM AUTHOR]

Aims The Randomized Injectable Opioid Treatment Trial ( RIOTT) compared supervised injectable heroin ( SIH) and supervised injectable methadone ( SIM) with optimized oral methadone ( OOM) ( ISRCTN0133807). Heroin addicts (previously unresponsive to treatment) made significant reductions in street heroin use at 6 months when treated with SIH. We now examine secondary outcomes. Design Multi-site randomized controlled trial ( RCT) comparing SIH versus OOM and SIM versus OOM. Setting Three supervised injectable opiate clinics in England. Participants Chronic refractory heroin addicts continuing to inject street heroin virtually daily despite oral substitution treatment ( n = 127), randomized to either SIH( n = 43), SIM( n = 42) or OOM( n = 42). All received high levels of medical and psychosocial support. Measurements Secondary outcomes: wider drug use, crime, health and social functioning at 6 months. Findings At 6 months, no significant differences were found between treatment groups in wider drug use (crack/cocaine, benzodiazepines, alcohol), physical and mental health ( SF-36) or social functioning. Within each treatment group, significant reductions were observed in crime [ SIH = odds ratio ( OR) 0.05; P < 0.001; SIM = OR 0.11; P = 0.002; OOM = OR 0.11; P = 0.003] and money spent per week on illicit drugs ( SIH = mean change £-289.43; P < 0.001; SIM = mean change £-183.41; P < 0.001; OOM = mean change £-162.80; P < 0.001), with SIH significantly more likely to have reduced money spent on illicit drugs versus OOM (mean difference £-92.04; P < 0.001). Significant improvements were seen in physical health for SIH and SIM ( SIH = mean change 3.97; P = 0.008; SIM = mean change 4.73; P = 0.002) and mental health for OOM (mean change 6.04; P = 0.013). Conclusions Supervised injectable heroin treatment and supervised injectable methadone treatment showed no clearly identified benefit over optimized oral methadone in terms of wider drug use, crime, physical and mental health within a 6-month period, despite reducing street heroin use to a greater extent. However, all interventions were associated with improvements in these outcomes. [ABSTRACT FROM AUTHOR]

Aims To evaluate a heroin overdose management training programme for family members based on emergency recovery procedures and take-home naloxone ( THN) administration. Design A two-group, parallel-arm, non-blinded, randomized controlled trial of group-based training versus an information-only control. Setting Training events delivered in community addiction treatment services in three locations in England. Participants A total of 187 family members and carers allocated to receive either THN training or basic information on opioid overdose management ( n = 95 and n = 92, respectively), with 123 participants completing the study. Measurements The primary outcome measure was a self-completion Opioid Overdose Knowledge Scale ( OOKS; range 0-45) and an Opioid Overdose Attitudes Scale ( OOAS; range 28-140) was the secondary outcome measure. Each group was assessed before receiving their assigned condition and followed-up 3 months after. Events of witnessing and managing an overdose during follow-up were also recorded. Findings At follow-up, study participants who had received THN training reported greater overdose-related knowledge relative to those receiving basic information only [ OOKS mean difference, 4.08 (95% confidence interval, 2.10-6.06; P < 0.001); Cohen's d = 0.74 (0.37-1.10)]. There were also more positive opioid overdose-related attitudes among the trained group at follow-up [ OOAS mean difference, 7.47 (3.13-11.82); P = 0.001; d = 0.61 (0.25-0.97)]. At the individual level 35 and 54%, respectively, of the experimental group increased their knowledge and attitudes compared with 11 and 30% of the control group. During follow-up, 13 participants witnessed an overdose with naloxone administered on eight occasions: five among the THN-trained group and three among the controls. Conclusions Take-home naloxone training for family members of heroin users increases opioid overdose-related knowledge and competence and these benefits are well retained after 3 months. [ABSTRACT FROM AUTHOR]

Background Behavioural change interventions for persons with chronic illness draw on a variety of theoretical approaches including motivational interviewing and shared decision making. Health literacy provides an additional, potentially powerful explanatory framework to guide research and practice. Objective To examine the changes in the depth and detail of diabetes-related knowledge and confidence for persons with type 2 diabetes. Design Two-year, prospective, observational study, using questionnaire data at two time points (baseline and 2 years later) and in-depth interviews with a theoretically selected subsample. Setting and participants A total of 319 patients initially recruited from a deprived urban area in north-west England Intervention Dedicated tele-carer education and support, tailored to the individual circumstances of the patient. Main outcome measures Perceptions of confidence, levels of empowerment, learning for self-care and most helpful aspects of the intervention. Results Over 90% expressed confidence in keeping their blood sugar controlled, and high levels of perceived empowerment (mean = 4.25; 95% CI, 4.17-4.33) were found. Changes in the depth and detail of diabetes-related knowledge and confidence, from the specific to the more general, were observed and enhanced competence in translating knowledge into practice. Discussion and conclusions The intervention, built within a developed working partnership between tele-carer and patient, operated at two levels: health literacy, enhancing knowledge, developing personal skills and enabling self-control; and socio-psychological behavioural change, tailored to individuals within their socio-economic environments, enabling increased motivation and supportive problem-solving. Both approaches find reflection in the findings and provide powerful explanatory lenses to interrogate the data. [ABSTRACT FROM AUTHOR]