A cluster randomised controlled trial of the effect of a treatment algorithm for hypertension in patients with type 2 diabetes

BACKGROUND: Good blood pressure (BP) control reduces the risk of complications in people with type 2 diabetes, yet many do not achieve this. Guidelines for managing hypertension recommend increasing antihypertensive medications until control is achieved, but the effect of such recommendations in routine primary care is unknown. AIM: To evaluate the effectiveness of a BP treatment algorithm in primary care patients with type 2 diabetes. DESIGN OF STUDY: A cluster randomised controlled trial of 1534 patients with type 2 diabetes. SETTING: Forty-two practices in Nottingham, UK. METHOD: Practices were randomised to continue usual care or to use a treatment algorithm designed so that practice nurses and GPs would increase antihypertensive treatment in steps until the target of 140/80 mmHg was reached. Participants were assessed by a clinical interview and case note review at recruitment and at 1 year. The primary outcome measure was the proportion of participants achieving target BP at 1 year. RESULTS: At 1 year there was no difference between the proportions of participants with well controlled BP in the intervention and control arms (36.6% versus 34.3%; P = 0.27). Mean systolic and diastolic blood pressures were identical in the two arms (143/78 mmHg). There was some evidence that participants in the intervention arm were more likely to be receiving higher doses of their antihypertensive drugs, although there was no significant difference in the number of different antihypertensive drugs prescribed. Participants in the intervention arm had a higher rate of primary care BP-related consultations over 12 months than those receiving usual care (rate ratio = 1.55, 95% confidence interval [CI] = 1.26 to 1.88, P<0.001). CONCLUSION: Despite increased monitoring and possibly higher doses of medication there was no improvement in blood pressure control. Improvements achieved by specialist nurse-led clinics in secondary care may not translate to people with type 2 diabetes in primary care settings.     

A randomised controlled trial of sensory awareness training and additional motor practice for learning scalpel skills in podiatry students

Background

The process of using a scalpel, like all other motor activities, is dependent upon the successful integration of afferent (sensory), cognitive and efferent (motor) processes. During learning of these skills, even if motor practice is carefully monitored there is still an inherent risk involved. It is also possible that this strategy could reinforce high levels of anxiety experienced by the student and affect student self-efficacy, causing detrimental effects on motor learning. An alternative training strategy could be through targeting sensory rather than motor processes.

Methods

Second year podiatry students who were about to commence learning scalpel skills were recruited. Participants were randomly allocated into sensory awareness training (Sensory), additional motor practice (Motor) or usual teaching only (Control) groups. Participants were then evaluated on psychological measures (Intrinsic Motivation Inventory) and dexterity measures (Purdue Pegboard, Grooved Pegboard Test and a grip-lift task).

Results

A total of 44 participants were included in the study. There were no baseline differences or significant differences between the three groups over time on the Perceived Competence, Effort/ Importance or Pressure/ Tension, psychological measures. All groups showed a significant increase in Perceived Competence over time (F_1,41?=?13.796, p?=?0.001). Only one variable for the grip-lift task (Preload Duration for the non-dominant hand) showed a significant difference over time between the groups (F_2,41?=?3.280, p?=?0.038), specifically, Motor and Control groups.

Conclusions

The use of sensory awareness training, or additional motor practice did not provide a more effective alternative compared with usual teaching. Further research may be warranted using more engaged training, provision of supervision and greater participant numbers.

Trial registration

Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616001428459. Registered 13^th October 2016. Registered Retrospectively.

     

Maintenance N-acetyl cysteine treatment for bipolar disorder: A double-blind randomised placebo controlled trial

ABSTRACT: BACKGROUND: N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder. METHOD: The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of [greater than or equal to]12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes. RESULTS: There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures. CONCLUSIONS: There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. Trial Registration The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493).     

The effect of salutogenic treatment principles on coping with mental health problems A randomised controlled trial

ObjectiveThe importance of psychosocial counselling after a diagnosis of cancer has been acknowledged and many intervention studies have been carried out, with the aim to find out which types of intervention are most effective in enhancing quality of life in cancer patients. A factor which could be part of effective counselling could be the time of offering psychosocial counselling. The aim of this study was to research the effect of time of enrolment in a psychosocial group intervention on psychosocial adjustment.MethodsIn the present study, 67 women with early stage breast cancer were randomised in a psychosocial group intervention program starting within 4 months after surgery or in the same intervention program starting at least 3 months later.ResultsThe main conclusion of this study is that women who started with their intervention early were less distressed at 6 months follow-up than women who were in the delayed condition. Medical and demographic variables were predictive for some psychosocial adjustment indicators, but were not associated with time of enrolment. Regardless of time of enrolment, women improved in distress, body image and recreational activities, but showed a decrease in social interaction.ConclusionThough results are limited, based on these results we suggest that psychosocial counselling should be offered as soon after diagnosis or surgery for breast cancer.Practice implicationsWomen diagnosed with primary breast cancer should be able to start with psychological counselling soon after being diagnosed, to prevent them from becoming distressed at long term.     

Efficacy of a cognitive-behavioral treatment for generalized anxiety disorder: evaluation in a controlled clinical trial

Recent advances in the understanding of worry have led to the development of treatments for generalized anxiety disorder (GAD). The present study tested a GAD treatment that targeted intolerance of uncertainty, erroneous beliefs about worry, poor problem orientation, and cognitive avoidance. Twenty-six primary GAD patients were randomly allocated to a treatment condition (n = 14) or a delayed treatment control condition (n = 12). Self-report, clinician, and significant other ratings assessed GAD and associated symptoms. The results show that the treatment led to statistically and clinically significant change at posttest and that gains were maintained at 6- and 12-month follow-ups. Furthermore, 20 of 26 participants (77%) no longer met GAD diagnostic criteria following treatment. With regard to the treatment's underlying model, the results show that intolerance of uncertainty significantly decreased over treatment and that gains were maintained at both follow-ups. Although nonspecific factors were not significant predictors of treatment outcome, their role in the treatment of GAD requires further investigation.     

The effect of an educational programme consisting of group and individual arthritis education for patients with polyarthritis--a randomised controlled trial

Objective

The aim of this study was to investigate the effect of an educational programme for patients with polyarthritis compared to usual care.

Methods

Patients with rheumatoid arthritis, psoriatic arthritis and unspecified polyarthritis were randomised to the intervention (n = 71) or usual care (n = 70). The intervention consisted of three group educational sessions followed by one individual educational session. The primary outcomes were a patient's global well-being and arthritis self-efficacy. Secondary outcomes were patient activation, physical and psychological health status, educational needs and disease activity.

Results

After four months the intervention group had significantly better global well-being, 95% CI (2.3–14.1), p = 0.01, and self-efficacy, 95% CI (0.2–8.1), p = 0.04, than the control group. There were also trends for improved disease activity, and a statistically significant improvement in patient activation and pain in the intervention group.

Conclusion

This patient educational programme consisting of group sessions and nurse-delivered individual education has statistically significant benefits for global well-being and maintaining a level of self-efficacy in managing other symptoms in patients with polyarthritis.

Practice implications

This educational programme allows patients to learn from each other in addition to addressing individual educational needs.     

Limitations of student-driven formative assessment in a clinical clerkship. A randomised controlled trial

Background  

Teachers strive to motivate their students to be self-directed learners. One of the methods used is to provide online formative assessment material. The concept of formative assessment and use of these processes is heavily promoted, despite limited evidence as to their efficacy.     

Family-based intervention by pharmacists for type 2 diabetes: A randomised controlled trial

Objectives

To investigate the effectiveness of family intervention for type 2 diabetes and to examine predictors of glycaemic control.

Nurse-led health coaching programme to improve hospital-to-home transitional care for stroke survivors: A randomised controlled trial

ObjectiveTo evaluate the effects of a nurse-led health coaching programme for stroke survivors and family caregivers in hospital-to-home transition care.MethodsA total of 140 dyads of stroke survivors and their family caregivers were recruited and randomly assigned to either the intervention group (received a 12-week nurse-led health coaching programme) or the usual care group. The primary outcome was self-efficacy, and secondary outcomes were quality of life (QoL), stroke-related knowledge, and caregiver-related burden. The outcomes were measured at baseline, 12 and 24 weeks.ResultsStroke survivors in the intervention group demonstrated a significant improvement in self-efficacy at 12 weeks (x?: 24.9, 95%CI: 20.2–29.6, p < 0.001) and at 24 weeks (x?: 23.9, 95%CI: 19.2–28.6, p < 0.001) compared to the usual care group. Findings also demonstrated significant increases in stroke survivors’ QoL, stroke-related knowledge, and reduction in unplanned hospital readmissions and caregiver-related burden. There were no statistically significant changes in other outcomes between the two groups.ConclusionThe nurse-led health coaching programme improved health outcomes for both stroke survivors and their caregivers.Practice ImpactionFindings from the study suggest that nurse-led health coaching should be incorporated into routine practice in hospital-to-home transitional care for stroke survivors and their caregivers.     

A randomised controlled trial of lay-led self-management for people with multiple sclerosis

Objective

To determine the impact of the Chronic Disease Self-Management Course (CDSMC) on people with multiple sclerosis (MS).

Methods

2-group, randomised, controlled trial with Intervention Group (IG) and Waiting-List Control Group (WLCG). Additional data were collected from a Comparison Group (CG) who chose not to attend the CDSMC. Participants completed baseline questionnaires; IG participants attended the CDSMC immediately; all participants were assessed at 4-months and 12-months.

Results

216 baseline questionnaires were returned; 73% were female, mean age 51.1 years, mean disease duration 12.0 years. Results showed that the CDSMC had an impact on self-management self-efficacy (ES 0.30, p = 0.009 for the IG) and MSIS physical status (ES 0.12 for the IG, p = 0.005). There were no other statistically significant changes. However, trends towards improvement on depression (ES 0.21 for the IG, p = 0.05) and MS self-efficacy (ES 0.16 for the IG, p = 0.04) were noted. All improvements were maintained at 12-months. At baseline, CG participants were older, had longer disease duration (p < 0.01) and less anxiety (p = 0.009) compared to RCT participants.

Conclusion

The CDSMC provides some small positive effects for people with MS. Motivation to attend may be linked to psychological distress and disease duration.

Practice implications

The CDSMC may be of value for those with mild anxiety/depression who need extra support. Attendance early in the disease course is recommended.     

舍曲林合并喹硫平治疗强迫症的随机对照研究

目的:探讨舍曲林合并喹硫平治疗强迫症的疗效和安全性。方法:86例符合国际疾病分类第10版(ICD-10)诊断标准的强迫症患者随机分为舍曲林合并喹硫平组(简称合用组,N=43)和单用舍曲林组(简称单用组,N=43),疗程8周。采用耶鲁-布朗强迫症量表(Yale-Brown Obsessive Compulsive Scale,Y-BOCS)、汉密顿焦虑量表(Hamilton Depression Scale,HAMA)评定疗效,采用治疗中需处理的不良反应症状量表(Treatment Emergent Symptoms Scale,TESS)评定安全性。结果:单用组有1例脱落而未纳入统计分析。在8周末,合用组的显效率高于单用组(72.1%vs.47.6%,P0.05);两组治疗后Y-BOCS、HAMA评分均低于治疗前[如,合用组Y-BOCS评分(11.74±4.50)vs.(25.00±5.19),P0.001];两组治疗后合用组Y-BOCS、HAMA评分低于单用组[如,Y-BOCS评分合用组(11.74±4.50)vs.单用组(14.38±4.18),P0.001]。两组TESS评分在治疗后第2、4、6及8周末差异均无统计学意义(均P0.05)。合用组困倦和心率过速的发生率高于单用组(37.2%vs.4.8%;27.9%vs.4.8%,P0.001或0.05),但多在2周内消失。其他常见不良反应,如,恶心、焦虑、头痛、便秘两组差异均无统计学意义(均P0.05)。结论:舍曲林合并小剂量喹硫平治疗强迫症可提高疗效,安全性较好,是一种值得借鉴的策略。     

A randomised controlled trial of a self-management plan for patients with newly diagnosed angina.

BACKGROUND: There are approximately 1.8 million patients with angina in the United Kingdom, many of whom report a poor quality of life, including raised levels of anxiety and depression. AIM: To evaluate the effect of a cognitive behavioural disease management programme, the Angina Plan, on psychological adjustment in patients newly diagnosed with angina pectoris. DESIGN OF STUDY: Randomised controlled trial. SETTING: Patients from GP practices in a Northern UK city (York) between April 1999 and May 2000. METHOD: Recruited patients were randomised to receive the Angina Plan or to a routine, practice nurse-led secondary prevention educational session. RESULTS: Twenty of the 25 practices invited to join the study supplied patients' names; 142 patients attended an assessment clinic and were randomised There were no significant differences in any baseline measures. At the six month post-treatment follow-up, 130 (91%) patients were reassessed. When compared with the educational session patients (using analysis of covariance adjusted for baseline scores in an intention-to-treat analysis) Angina Plan patients showed a greater reduction in anxiety (P = 0.05) and depression (P = 0.01), the frequency of angina (reduced by three episodes per week, versus a reduction of 0.4 per week, P = 0.016) the use of glyceryl trinitrate (reduced by 4.19 fewer doses per week versus a reduction of 0.59 per week, P = 0.018), and physical limitations (P<0.001: Seattle Angina Questionnaire). They were also more likely to report having changed their diet (41 versus 21, P<0.001) and increased their daily walking (30 versus 2, P<0.001). There was no significant difference between the groups on the other sub-scales of the Seattle Angina Questionnaire or in any of the medical variables measured. CONCLUSION: The Angina Plan appears to improve the psychological, symptomatic, and functional status of patients newly diagnosed with angina.     

Educational intervention for older people with asthma: A randomised controlled trial

ObjectivesTo improve the asthma control and adherence to asthma preventer medication of older people using the Patient Asthma Concerns Tool (PACT) to identify and address unmet needs and patient concerns.MethodsCommunity dwelling adults over 55 years, living in Victoria or New South Wales were recruited into a single-blind, parallel design, randomised-controlled trial comparing person-centred education including device technique, versus written information-only education. Fifty-eight participants randomised to the intervention group and 56 to the control completed participation. Outcome measures: asthma control, adherence to preventer medication, asthma related quality of life, asthma exacerbations and written action plan ownership were assessed at baseline, and 3 and 12 months post intervention.ResultsIntervention participants experienced improvements in asthma control, adherence to asthma preventer medication, reduced exacerbations, improved quality of life and an increase in asthma action plan ownership at 3 and 12 months.ConclusionAsthma outcomes in older people can be significantly improved by delivering tailored education that identifies specific patient concerns and unmet needs.Practical implicationsUse of the PACT to identify patient concerns and unmet needs will assist health professionals to improve the health literacy of patients by addressing gaps in their knowledge and perceptions of asthma control.     

Educational intervention for older people with asthma: A randomised controlled trial

Objectives

To improve the asthma control and adherence to asthma preventer medication of older people using the Patient Asthma Concerns Tool (PACT) to identify and address unmet needs and patient concerns.

Methods

Community dwelling adults over 55 years, living in Victoria or New South Wales were recruited into a single-blind, parallel design, randomised-controlled trial comparing person-centred education including device technique, versus written information-only education. Fifty-eight participants randomised to the intervention group and 56 to the control completed participation. Outcome measures: asthma control, adherence to preventer medication, asthma related quality of life, asthma exacerbations and written action plan ownership were assessed at baseline, and 3 and 12 months post intervention.

Results

Intervention participants experienced improvements in asthma control, adherence to asthma preventer medication, reduced exacerbations, improved quality of life and an increase in asthma action plan ownership at 3 and 12 months.

Conclusion

Asthma outcomes in older people can be significantly improved by delivering tailored education that identifies specific patient concerns and unmet needs.

Practical implications

Use of the PACT to identify patient concerns and unmet needs will assist health professionals to improve the health literacy of patients by addressing gaps in their knowledge and perceptions of asthma control.     

A randomised controlled trial of motivational interviewing for smoking cessation

BACKGROUND: Motivational interviewing is a technique used to promote change in addictive behaviour, initially used to treat alcoholism. Despite this, its effectiveness has not been sufficiently demonstrated for giving up smoking. AIM: The aim of the study was to establish whether motivational interviewing, compared with anti-smoking advice, is more effective for giving up the habit. DESIGN OF STUDY: Randomised controlled trial. SETTING: Primary care in Albecete, Spain. METHOD: Random experimental study of 200 smokers assigned to two types of interventions: anti-smoking advice (n = 86) and motivational interviewing (n = 114). Subjects in both groups were offered bupropion when nicotine dependency was high (Fagerstr?m score >7). The success rate was evaluated by intention to treat; point prevalence abstinence was measured 6 and 12 months post intervention by personal testimony, confirmed by means of CO-oximetry (value < 6ppm). RESULTS: The measure of effectiveness of the treatment for giving up smoking after both 6 and 12 months, showed that the motivational interviewing action was 5.2 times higher than anti-smoking advice (18.4 % compared to 3.4%; 95% confidence interval = 1.63 to 17.13). CONCLUSION: The results of our study show that motivational interviewing is more effective than brief advice for giving up smoking.     

A randomised controlled trial of clinics in secondary schools for adolescents with asthma.

AIM: To compare a nurse-led clinic in schools versus care in general practice for adolescents with asthma. DESIGN OF STUDY: Randomised controlled trial in four schools; parallel observational study in two schools. SETTING: Six comprehensive schools. METHOD: In the randomised trial, pupils were invited to attend asthma review at a nurse-led clinic either in school, or in general practice. The parallel observational study compared pupils invited to practice care within and outside the randomised trial. Primary outcome measures were attendance for asthma review, symptom control, and quality of life. Secondary outcomes were knowledge, attitudes, inhaler technique, use of steroids, school absence, peak flow rate, preference for future care, health service utilisation, and costs. RESULTS: School clinic pupils were more likely to attend an asthma review than those randomised to practice care (90.8% versus 51.0% overall [P < 0.001, not consistent across schools]). No differences were observed in symptom control (P = 0.42) or quality of life (P = 0.63). Pupils attending school clinics had greater knowledge of asthma (difference = +0.38, 95% CI = 0.19 to 0.56), more positive attitudes (difference = +0.21, 95% CI = 0.05 to 0.36), and better inhaler technique (P < 0.001, not consistent across all schools). No differences were observed in school absence or peak flow rate. A majority (63%) of those who had received care at school preferred this model in future. Median costs of providing care at school and at the practice were 32.10 Pounds and 19.80 Pounds, respectively. No differences were observed between the groups in the observational comparison on any outcome. CONCLUSIONS: The schools asthma clinic increased uptake of asthma reviews. There were improvements in various process measures, but not in clinical outcomes.     

The effect of educational intervention on intercultural communication: results of a randomised controlled trial

BACKGROUND: Due to worldwide migration to Western countries, physicians are increasingly encountering patients with different ethnic backgrounds. Communication problems can arise as a result of differences in cultural backgrounds and poor language proficiency. AIMS: To assess the effectiveness of an educational intervention on intercultural communication aimed to decrease inequalities in care provided between Western and non-Western patients. DESIGN OF STUDY: A randomised controlled trial with randomisation at the GP level and outcome measurements at the patient level. SETTING: General practice in Rotterdam. METHOD: Thirty-eight Dutch GPs in the Rotterdam region, with at least 25% of inhabitants of non-Western origin, and 2407 visiting patients were invited to participate in the study. A total of 986 consultations were finally included. The GPs were educated about cultural differences and trained in intercultural communication. Patients received a videotaped instruction focusing on how to communicate with their GP in a direct way. The primary outcome measure was mutual understanding and the secondary outcomes were patient's satisfaction and perceived quality of care. The intervention effect was assessed for all patients together, for the 'Western' and 'non-Western' patients, and for patients with different cultural backgrounds separately. RESULTS: An intervention effect was seen 6 months after the intervention, as improvement in mutual understanding (and some improvement in perceived quality of care) in consultations with 'non-Western' patients. CONCLUSIONS: A double intervention on intercultural communication given to both physician and patient decreases the gap in quality of care between 'Western' and 'non-Western' patients.