A multicentre randomized controlled trial of an empowerment-inspired intervention for adolescents starting continuous subcutaneous insulin infusion : a study protocol

Background. Continuous subcutaneous insulin infusion (CSII) treatment among children with type 1 diabetes is increasing in Sweden. However, studies evaluating glycaemic control in children using CSII show inconsistent results. Omitting bolus insulin doses using CSII may cause reduced glycaemic control among adolescents. The distribution of responsibility for diabetes self-management between children and parents is often unclear and needs clarification. There is much published support for continued parental involvement and shared diabetes management during adolescence. Guided Self-Determination (GSD) is an empowerment-based, person-centred, reflection and problem solving method intended to guide the patient to become self-sufficient and develop life skills for managing difficulties in diabetes self-management. This method has been adapted for adolescents and parents as Guided Self-Determination-Young (GSD-Y). This study aims to evaluate the effect of an intervention with GSD-Y in groups of adolescents starting on insulin pumps and their parents on diabetes-related family conflicts, perceived health and quality of life (QoL), and metabolic control. Here, we describe the protocol and plans for study enrolment. Methods. This study is designed as a randomized, controlled, prospective, multicentre study. Eighty patients between 12-18 years of age who are planning to start CSII will be included. All adolescents and their parents will receive standard insulin pump training. The education intervention will be conducted when CSII is to be started and at four appointments in the first 4 months after starting CSII. The primary outcome is haemoglobin A1c levels. Secondary outcomes are perceived health and QoL, frequency of blood glucose self-monitoring and bolus doses, and usage of carbohydrate counting. The following instruments will be used to evaluate perceived health and QoL: Disabkids, 'Check your health', the Diabetes Family Conflict Scale and the Swedish Diabetes Empowerment Scale. Outcomes will be evaluated within and between groups by comparing data at baseline, and at 6 and 12 months after starting treatment. Results and discussion. In this study, we will assess the effect of starting an insulin pump together with the model of Guided Self-Determination to determine whether this approach leads to retention of improved glycaemic control, QoL, responsibility distribution and reduced diabetes-related conflicts in the family. Trial registration: Current controlled trials: ISRCTN22444034

Self-assessment of the outcome of early medical abortion versus clinic follow-up in India : a randomised, controlled, non-inferiority trial

Background: The need for multiple clinical visits remains a barrier to women accessing safe legal medical abortion services. Alternatives to routine clinic follow-up visits have not been assessed in rural low-resource settings. We compared the effectiveness of standard clinic follow-up versus home assessment of outcome of medical abortion in a low-resource setting. Methods: This randomised, controlled, non-inferiority trial was done in six health centres (three rural, three urban) in Rajasthan, India. Women seeking early medical abortion up to 9 weeks of gestation were randomly assigned (1:1) to either routine clinic follow-up or self-assessment at home. Randomisation was done with a computer-generated randomisation sequence, with a block size of six. The study was not blinded. Women in the home-assessment group were advised to use a pictorial instruction sheet and take a low-sensitivity urine pregnancy test at home, 10-14 days after intake of mifepristone, and were contacted by a home visit or telephone call to record the outcome of the abortion. The primary (non-inferiority) outcome was complete abortion without continuing pregnancy or need for surgical evacuation or additional mifepristone and misoprostol. The non-inferiority margin for the risk difference was 5%. All participants with a reported primary outcome and who followed the clinical protocol were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT01827995. Findings: Between April 23, 2013, and May 15, 2014, 731 women were recruited and assigned to clinic follow-up (n=366) or home assessment (n=365), of whom 700 were analysed for the main outcomes (n=336 and n=364, respectively). Complete abortion without continuing pregnancy, surgical intervention, or additional mifepristone and misoprostol was reported in 313 (93%) of 336 women in the clinic follow-up group and 347 (95%) of 364 women in the home-assessment group (difference -2.2%, 95% CI -5.9 to 1.6). One case of haemorrhage occurred in each group (rate of adverse events 0.3% in each group); no other adverse events were noted. Interpretation Home assessment of medical abortion outcome with a low-sensitivity urine pregnancy test is non-inferior to clinic follow-up, and could be introduced instead of a clinic follow-up visit in a low-resource setting.

Validation of a food-frequency questionnaire assessment of carotenoid and vitamin E intake using weighed food records and plasma biomarkers: the method of triads model.

Background: Reliability or validity studies are important for the evaluation of measurement error in dietary assessment methods. An approach to validation known as the method of triads uses triangulation techniques to calculate the validity coefficient of a food-frequency questionnaire (FFQ).

Objective: To assess the validity of an FFQ estimates of carotenoid and vitamin E intake against serum biomarker measurements and weighed food records (WFRs), by applying the method of triads. Design: The study population was a sub-sample of adult participants in a randomised controlled trial of b-carotene and sunscreen in the prevention of skin cancer. Dietary intake was assessed by a self-administered FFQ and a WFR. Nonfasting blood samples were collected and plasma analysed for five carotenoids (a-carotene, b-carotene, b-cryptoxanthin, lutein, lycopene) and vitamin E. Correlation coefficients were calculated between each of the dietary methods and the validity coefficient was calculated using
the method of triads. The 95% confidence intervals for the validity coefficients were estimated using bootstrap sampling.

Results: The validity coefficients of the FFQ were highest for a-carotene (0.85) and lycopene (0.62), followed by b-carotene (0.55) and total carotenoids (0.55), while the lowest validity coefficient was for lutein (0.19). The method of triads could not be used for b-cryptoxanthin and vitamin E, as one of the three underlying correlations was negative.

Conclusions: Results were similar to other studies of validity using biomarkers and the method of triads. For many dietary factors, the upper limit of the validity coefficients was less than 0.5 and therefore only strong relationships between dietary exposure and disease will be detected.

Targeted clinical education for staff attitudes towards deliberate self-harm in borderline personality disorder : randomized controlled trial

Objective: The aim of the present study was to assess the impact of attending targeted clinical education on borderline personality disorder on the attitudes of health clinicians towards working with deliberate self-harm behaviours commonly exhibited by patients diagnosed with this complex disorder. Comparisons of clinicians across service settings, occupational fields, and other demographic areas were also made.

Method: A purpose-designed demographic questionnaire and the Attitudes Towards Deliberate Self-Harm Questionnaire were used to collect the demographic information and assess the attitudes of 99 mental health and emergency medicine practitioners across two Australian health services and a New Zealand health service, both before and after education attendance.

Results: Statistically significant improvements in attitude ratings were found for both emergency medicine clinicians and mental health clinicians in working with deliberate self-harm behaviours in borderline personality disorder, following attendance at the education program with a medium affect size (t(32)=−3.45, p=0.002, d=0.43 and t(65)=−5.12, p=0.000, d=0.42, respectively). Clinicians across occupational areas of nursing, allied health, and medical fields demonstrated equivocal levels of improvement in their attitude ratings.

Conclusions: Results are discussed in terms of the necessity of providing regular access to targeted clinical education for health professionals working with patients diagnosed with borderline personality disorder.

Effectiveness of a community-based osteoporosis education and self-management course : a wait list controlled trial

Summary : Osteoporosis is an increasing burden on individuals and health resources. The Osteoporosis Prevention and Self-Management Course (OPSMC) was designed to assist individuals to prevent and manage osteoporosis; however, it had not been evaluated in an Australian setting. This randomised controlled trial showed that the course increased osteoporosis knowledge.
Introduction and hypothesis : Osteoporosis is a major and growing public health concern. An OPSMC was designed to provide individuals with information and skills to prevent or manage osteoporosis, but its effectiveness has not previously been evaluated. This study aimed to determine whether OPSMC attendance improved osteoporosis knowledge, self-efficacy, self-management skills or behaviour.
Materials and methods : Using a wait list randomised controlled trial design, 198 people (92% female) recruited from the community and aged over 40 (mean age = 63) were randomised into control (n = 95) and intervention (n = 103) groups. The OPSMC consists of four weekly sessions which run for 2 h and are led by two facilitators. The primary outcome were osteoporosis knowledge, health-directed behaviour, self-monitoring and insight and self-efficacy.
Results : The groups were comparable at baseline. At 6-week follow-up, the intervention group showed a significant increase in osteoporosis knowledge compared with the control group; mean change 3.5 (p < 0.001) on a measure of 0–20. The intervention group also demonstrated a larger increase in health-directed behaviour, mean change 0.16 (p < 0.05), on a measure of 0–6.
Conclusion : The results indicate that the OPSMC is an effective intervention for improving understanding of osteoporosis and some aspects of behaviour in the short term.

Getting your life back on track after stroke : a phase II multi-centered, single-blind, randomized, controlled trial of the Stroke Self-Management Program vs. the Stanford Chronic Condition Self-Management Program or standard care in stroke survivors

Background Self-management is seen as a primary mechanism to support the optimization of care for people with chronic diseases such as symptomatic vascular disease. There are no established and evidence-based stroke-specific chronic disease self-management programs. Our aim is to evaluate whether a stroke-specific program is safe and feasible as part of a Phase II randomized-controlled clinical trial.
Methods Stroke survivors are recruited from a variety of sources including: hospital stroke services, local paper advertisements, Stroke South Australia newsletter (volunteer peer support organization), Divisions of General Practice, and community service providers across Adelaide, South Australia. Subjects are invited to participate in a multi-center, single-blind, randomized, controlled trial. Eligible participants are randomized to either;
• standard care,
• standard care plus a six week generic chronic condition self-management group education program, or,
• standard care plus an eight week stroke specific self-management education group program.
Interventions are conducted after discharge from hospital. Participants are assessed at baseline, immediate post intervention and six months.
Study Outcomes The primary outcome measures determine study feasibility and safety, measuring, recruitment, participation, compliance and adverse events.
Secondary outcomes include:
• positive and active engagement in life measured by the Health Education Impact Questionnaire,
• improvements in quality of life measured by the Assessment of Quality of Life instrument,
• improvements in mood measured by the Irritability, Depression and Anxiety Scale,
• health resource utilization measured by a participant held diary and safety.

Conclusion The results of this study will determine whether a definitive Phase III efficacy trial is justified.

A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program

Background and Purpose—The benefits of chronic disease self-management programs for stroke survivors are uncertain because individuals with severe impairments have been excluded from previous research. We undertook a phase II randomized controlled trial to determine whether a self-management program designed for survivors (SSMP; 8 weeks) was safe and feasible compared to standard care (control) or a generic self-management program (generic; 6 weeks).
Methods—Stroke survivors were recruited from 7 South Australian hospitals via a letter or indirectly (eg, newspapers). Eligible participants were randomized at a 1:1:1 ratio of 50 per group. Primary outcomes were recruitment, participation, and participant safety. Secondary outcomes were positive and active engagement in life using the Health Education Impact Questionnaire and characteristics of quality of life and mood at 6 months from program completion.
Results—Of 315 people screened, 149 were eligible and 143 were randomized (48 SSMP, 47 generic, 48 control); mean age was 69 years (SD, 11) and 59% were female. Demographic features were similar between groups and 41% had severe cognitive impairment; 57% accessed the interventions, with 52% SSMP and 38% generic completing >50% of sessions (P=0.18). Thirty-two participants reported adverse events (7 control, 12 generic, 13 SSMP; P=0.3; 34% severe); however, none was attributable to the interventions. Potential benefits for improved mood were found.
Conclusions—SSMP was safe and feasible. Benefits of the stroke-specific program over the generic program included greater participation and completion rates. An efficacy trial is warranted given the forecast growth in the stroke population and improved survival trends.

Does self monitoring of blood blucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol

Background
The benefit of self-monitoring of blood glucose (SMBG) in people with type 2 diabetes on diet or oral agents other than sulphonylureas remains uncertain. Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results. A recent systematic review concluded that SMBG was not cost-effective. However, what was unclear was whether a cheaper method of self-monitoring (such as urine glucose monitoring) could produce comparable benefit and patient acceptability for less cost.

Methods/Design
The DESMOND SMBG trial is comparing two monitoring strategies (blood glucose monitoring and urine testing) over 18 months when incorporated into a comprehensive self-management structured education programme. It is a multi-site cluster randomised controlled trial, conducted across 8 sites (7 primary care trusts) in England, UK involving individuals with newly diagnosed Type 2 diabetes.

The trial has 80% power to demonstrate equivalence in mean HbA1c (the primary end-point) at 18 months of within ± 0.5% assuming 20% drop out and 20% non-consent. Secondary end-points include blood pressure, lipids, body weight and psychosocial measures as well as a qualitative sub-study.

Practices were randomised to one of two arms: participants attend a DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose. The programme is delivered by accredited educators who received specific training about equipoise. Biomedical data are collected and psychosocial scales completed at baseline, and 6, 12, and 18 months post programme. Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring.

Discussion
The DESMOND SMBG trial is designed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes. Strengths include a setting in primary care, a cluster design, a health economic analysis, a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub-study.

Factors limiting participation in arthritis self-management programmes : an exploration of barriers and patient preferences within a randomized controlled trial

Objective. To improve understanding of barriers to participation in community-based arthritis self-management programmes and patient preferences for self-management education.

Methods. Individuals with hip or knee OA referred to orthopaedic surgeons or rheumatologists at six public and private hospitals in Victoria, Australia, were recruited for a randomized controlled trial (RCT) of the Stanford Arthritis Self-Management Programme (ASMP). As part of the study design, potential participants were asked during the screening and recruitment process about reasons for being unable to attend the course, reasons for not participating in the study and individual preferences for course scheduling.

Results. Of 1125 individuals assessed, 216 (19%) were unable to attend six ASMP sessions. This was commonly due to physical limitations, including illness, restricted mobility and pain (22%), difficulty getting to or from courses (22%), work commitments (22%), the time commitment required (17%) and family roles (12%). Among those who did not want to participate in the study (n = 258), the overwhelming reason was disinterest (74%). Specific preferences for course scheduling were frequent, confirming the practical challenges faced in organizing courses for the RCT.

Conclusion. Incorporating patients from public and private settings, this study has elicited new insights into barriers to ASMP participation. Many people with hip or knee OA have limited capacity and motivation to attend community-based group programmes. Future self-management programmes and research should include more accessible options for those who cannot attend group-based programmes.

A parallel-group, randomised controlled trial of a multimedia, self-directed, coping skills training intervention for patients with cancer and their partners: design and rationale

Introduction:

Severe obesity and diabetes self-care attitudes, behaviours and burden: implications for weight management from a matched case-controlled study.

Aims
To investigate whether diabetes self-care attitudes, behaviours and perceived burden, particularly related to weight management, diet and physical activity, differ between adults with Type 2 diabetes who are severely obese and matched non-severely obese control subjects.

Methods
The 1795 respondents to the Diabetes MILES—Australia national survey had Type 2 diabetes and reported height and weight data, enabling BMI calculation: 530 (30%) were severely obese (BMI ≥ 35 kg/m2; median BMI = 41.6 kg/m2) and these were matched with 530 control subjects (BMI < 35 kg/m2; median BMI = 28.2 kg/m2). Diabetes self-care behaviours, attitudes and burden were measured with the Diabetes Self-Care Inventory—Revised. Within-group and between-group trends were examined.

Results
The group with BMI ≥ 35 kg/m2 was less likely to achieve healthy diet and exercise targets, placed less importance on diet and exercise recommendations, and found the burden of diet and exercise recommendations to be greater than the group with BMI < 35 kg/m2. The group with BMI ≥ 35 kg/m2 was more likely to be actively trying to lose weight, but found weight control a greater burden. These issues accentuated with increasing obesity and were greatest in those with BMI > 45 kg/m2. There were no between-group differences in other aspects of diabetes self-care: self-monitoring of blood glucose, use of medications and smoking. Moderate-to-severe symptoms of depression were independently associated with reduced likelihood of healthy diet and physical activity, and with greater burden associated with diet, physical activity and weight management.

Conclusions
Severely obese people with diabetes demonstrated self-care attitudes, behaviours and burdens that infer barriers to weight loss. However, other important diabetes self-care behaviours are supported equally by severely obese and non-severely obese individuals.

The Dutch Obesity Intervention in Teenagers (DOiT) cluster controlled implementation trial: intervention effects and mediators and moderators of adiposity and energy balance-related behaviours

 Background: The Dutch Obesity Intervention in Teenagers (DOiT) programme is an evidence-based obesity prevention programme tailored to adolescents attending the first two years of prevocational education in the Netherlands. The initial programme showed promising results during an effectiveness trial. The programme was adapted and prepared for nationwide dissemination. To gain more insight into the process of translating evidence-based approaches into ‘real world’ (i.e., ‘natural’) conditions, our research aims were to evaluate the impact of the DOiT-implementation programme on adolescents’ adiposity and energy balance-related behaviours during natural dissemination and to explore the mediating and moderating factors underlying the DOiT intervention effects.
Methods: We conducted a cluster-controlled implementation trial with 20 voluntary intervention schools (n=1002 adolescents) and 9 comparable control schools (n = 484 adolescents). We measured adolescents’ body height and weight, skinfold thicknesses, and waist circumference. We assessed adolescents’ dietary and physical activity behaviours by means of self-report. Data were collected at baseline and at 20-months follow-up. We used multivariable multilevel linear or logistic regression analyses to evaluate the intervention effects and to test the hypothesised behavioural mediating factors. We checked for potential effect modification by gender, ethnicity and education level.
Results: We found no significant intervention effects on any of the adiposity measures or behavioural outcomes. Furthermore, we found no mediating effects by any of the hypothesised behavioural mediators. Stratified analyses for gender showed that the intervention was effective in reducing sugar-containing beverage consumption in girls (B = -188.2 ml/day; 95% CI = -344.0; -32.3). In boys, we found a significant positive intervention effect on breakfast frequency (B = 0.29 days/week; 95% CI = 0.01; 0.58). Stratified analyses for education level showed an adverse intervention effect (B = 0.09; 95% CI = 0.02; 0.16) on BMI z-scores for adolescents attending the vocational education track.
Conclusions: Although not successful in changing adolescents’ adiposity, the DOiT-implementation programme had some beneficial effects on specific obesity-related behaviours in subgroups. This study underlines the difficulty of translating intervention effectiveness in controlled settings to real world contexts. Adaptations to the implementation strategy are needed in order to promote implementation as intended by the teachers.