scholarly journals A 10-year follow-up of tailored behavioural treatment and exercise-based physiotherapy for persistent musculoskeletal pain

2016 ◽  
Vol 31 (2) ◽  
pp. 186-196 ◽  
Author(s):  
Christina Emilson ◽  
Ingrid Demmelmaier ◽  
Stefan Bergman ◽  
Per Lindberg ◽  
Eva Denison ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Behavioural Medicine ◽  
Behavioural Treatment ◽  
Beneficial Effects ◽  
Maximum Pain ◽  
Secondary Outcomes ◽  
Randomised Controlled

Objective: To study the long-term outcomes of two interventions targeting patients with sub-acute and persistent pain in a primary care physiotherapy setting. Design: A 10-year follow-up of a two-armed randomised controlled trial, initially including 97 participants. Interventions: Tailored behavioural medicine treatment, applied in a physiotherapy context (experimental condition), and exercise-based physiotherapy (control condition). Main measures: Pain-related disability was the primary outcome. The maximum pain intensity, pain control, fear of movement, sickness-related absence (register data) and perceived benefit and confidence in coping with future pain problems were the secondary outcomes. Results: Forty-three (44%) participants responded to the follow-up survey, 20 in the tailored behavioural medicine treatment group and 23 in the exercise-based physiotherapy group. The groups did not differ in terms of the change in the scores for the primary outcome ( p=0.17) of pain-related disability between the experimental group (median: 2.5, Q1-Q3: -2.5-14.25), and the control group (median: 0, Q1-Q3: -5-6). Further, there were also no significant differences found for the secondary outcomes except for sickness-related absence, where the exercise-based physiotherapy group had more days of sickness-related absence three months before treatment ( p= 0.02), and at the 10-year follow-up ( p=0.03). Discussion: The beneficial effects favouring tailored behavioural medicine treatment that observed post-treatment and at the two-year follow-up were not maintained 10 years after treatment.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Testing the Efficacy of ‘Unlearning’, a Mindfulness and Compassion-Based Programme for Cultivating Nonviolence in Teenagers: A Randomised Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Irene Delgado-Suárez ◽  
Yolanda López-del-Hoyo ◽  
Javier García-Campayo ◽  
Adrián Pérez-Aranda ◽  
Marta Modrego-Alarcón ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Multiple Comparisons ◽  
Post Treatment ◽  
Control Group ◽  
Self Compassion ◽  
Baseline Levels ◽  
Secondary Outcomes ◽  
Randomised Controlled

Background: Most programmes developed to reduce aggressive attitudes among teenagers are based on cultivating nonviolence, a construct that has been related to compassion and, more indirectly, mindfulness. This study aims at testing the efficacy of ‘Unlearning’, a mindfulness and compassion-based programme, for reducing aggressive attitudes in adolescents.Method: A sample of 164 students from three high schools in Zaragoza (Spain) participated in the study. They were randomly assigned to (1) ‘Unlearning’, or (2) relaxation programme. Three assessment points were established: baseline, post-treatment and a 4-month follow-up. The outcome variables were the subscales of the ‘Attitudes Toward Social Aggression Scale’. Mindfulness and compassion were assessed as secondary outcomes.Results: ‘Unlearning’ did not produce changes in the primary outcomes, but significant effects were observed post-treatment in self-compassion; and in the follow-up, in self-compassion and mindfulness. The control group did not experience any change post-treatment, but a significant effect in mindfulness was observed in the follow-up. The intergroup analyses indicated that ‘Unlearning’ improved self-compassion, both post-treatment (t = −2.48, p = 0.014) and after 4-months (t = −2.03, p = 0.044), although these results were not statistically significant after correcting for multiple comparisons.Conclusion: ‘Unlearning’ did not produce significant reductions in aggressive attitudes compared to the control group. The low baseline levels may have hindered the efficacy of the interventions. ‘Unlearning’ showed potential to improve self-compassion, which is related to nonviolence, and this may have positive implications for the adolescents. Future interventions should include teachers and families to enhance the effectiveness of the programmes.

scholarly journals The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015111 ◽  
Author(s):  
Mohamed Abdel-Fattah ◽  
Graeme MacLennan ◽  
Mary Kilonzo ◽  
R Phil Assassa ◽  
Kirsty McCormick ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Single Incision ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Female Stress Urinary Incontinence ◽  
Midurethral Slings ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

scholarly journals Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040183
Author(s):  
Dominika Kwasnicka ◽  
Aleksandra Luszczynska ◽  
Martin S Hagger ◽  
Eleanor Quested ◽  
Sherry L Pagoto ◽  
...  
Keyword(s):  
Time Series ◽  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Weight Loss Maintenance ◽  
Control Group ◽  
Promote Weight Loss ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionDigital behavioural weight loss interventions have the potential to improve public health; however, these interventions are often not adequately tailored to the needs of the participants. This is the protocol for a trial that aims to determine the effectiveness and cost-effectiveness of the Choosing Health programme as a means to promote weight loss and weight loss maintenance among overweight/obese adults.Methods and analysisThe proposed study is a two-group randomised controlled trial with a nested interrupted time series (ITS) within-person design. Participants (n=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, ecological momentary assessment will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content.Control group participants will receive non-tailored weight loss advice via e-book and generic emails. The primary outcome is the mean difference in weight loss between groups at 6 months controlled for baseline. Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss. Secondary outcomes will be measured at baseline, 3, 6 and 12 months. The primary outcome for ITS will be daily weight loss plan adherence. Data will be analysed using regression and time series analyses.Ethics and disseminationEthics approval was granted by Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland, approval number 03/P/12/2019. The project results will be disseminated through structured strategy implemented in collaboration with the Ministry of Health.Trial registration detailsThis trial was registered with www.clinicaltrials.gov; registration number NCT04291482.

scholarly journals Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023017 ◽  
Author(s):  
Torunn Hatlen Nøst ◽  
Aslak Steinsbekk ◽  
Ola Bratås ◽  
Kjersti Grønning
Keyword(s):  
Chronic Pain ◽  
Healthcare Service ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Patient Activation ◽  
Self Management ◽  
Control Group ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectivesTo investigate the effects on persons with chronic pain after 3 months of a group-based chronic pain self-management course compared with a drop-in, low-impact outdoor physical group activity on patient activation and a range of secondary outcomes.DesignAn open, pragmatic, parallel group randomised controlled trial. Analyses were performed using a two-level linear mixed model.SettingAn easily accessible healthcare service provided by Norwegian public primary healthcare.ParticipantsA total of 121 participants with self-reported chronic pain for 3 months or more were randomised with 60 participants placed in the intervention group and 61 placed in the control group (mean age 53 years, 88% women, 63% pain for 10 years or more).InterventionsThe intervention group was offered a group-based chronic pain self-management course with 2.5-hour weekly sessions for a period of 6 weeks. The sessions consisted of education, movement exercises and emphasised group discussions. The control group was offered a low-impact outdoor group physical activity in 1-hour weekly sessions that consisted of walking and simple strength exercises for a period of 6 weeks.Main outcomesThe primary outcome was patient activation assessed using the Patient Activation Measure. Secondary outcomes measured included assessments of pain, anxiety and depression, pain self-efficacy, sense of coherence, health-related quality of life, well-being and the 30 s chair to stand test.ResultsThere was no effect after 3 months of the group-based chronic pain self-management course compared with the control group for the primary outcome, patient activation (estimated mean difference: −0.5, 95% CI –4.8 to 3.7, p=0.802).ConclusionsThere was no support for the self-management course having a better effect after 3 months than a low-impact outdoor physical activity offered the control group.Trial registration numberNCT02531282; Results.

scholarly journals Affect-Focused Psychodynamic Internet-Based Therapy for Adolescent Depression: Randomized Controlled Trial

10.2196/18047 ◽  
2020 ◽  
Vol 22 (3) ◽  
pp. e18047 ◽  
Author(s):  
Karin Lindqvist ◽  
Jakob Mechler ◽  
Per Carlbring ◽  
Peter Lilliengren ◽  
Fredrik Falkenström ◽  
...  
Keyword(s):  
Emotion Regulation ◽  
Adolescent Depression ◽  
Primary Outcome ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Self Compassion ◽  
Randomised Controlled

Background Adolescent depression is one of the largest health issues in the world and there is a pressing need for effective and accessible treatments. Objective This trial examines whether affect-focused internet-based psychodynamic therapy (IPDT) with therapist support is more effective than an internet-based supportive control condition on reducing depression in adolescents. Methods The trial included 76 adolescents (61/76, 80% female; mean age 16.6 years), self-referred via an open access website and fulfilling criteria for major depressive disorder. Adolescents were randomized to 8 weeks of IPDT (38/76, 50%) or supportive control (38/76, 50%). The primary outcome was self-reported depressive symptoms, measured with the Quick Inventory of Depressive Symptomatology for Adolescents (QIDS-A17-SR). Secondary outcomes were anxiety severity, emotion regulation, self-compassion, and an additional depression measure. Assessments were made at baseline, postassessment, and at 6 months follow-up, in addition to weekly assessments of the primary outcome measure as well as emotion regulation during treatment. Results IPDT was significantly more effective than the control condition in reducing depression (d=0.82, P=.01), the result of which was corroborated by the second depression measure (d=0.80, P<.001). IPDT was also significantly more effective in reducing anxiety (d=0.78, P<.001) and increasing emotion regulation (d=0.97, P<.001) and self-compassion (d=0.65, P=.003). Significantly more patients in the IPDT group compared to the control group met criteria for response (56% vs 21%, respectively) and remission (35% vs 8%, respectively). Results on depression and anxiety symptoms were stable at 6 months follow-up. On average, participants completed 5.8 (SD 2.4) of the 8 modules. Conclusions IPDT may be an effective intervention to reduce adolescent depression. Further research is needed, including comparisons with other treatments. Trial Registration International Standard Randomised Controlled Trial Number (ISRCTN) 16206254; http://www.isrctn.com/ISRCTN16206254

scholarly journals Effectiveness of a volunteer befriending programme for patients with schizophrenia: randomised controlled trial

2019 ◽  
Vol 217 (3) ◽  
pp. 477-483 ◽  
Author(s):  
Stefan Priebe ◽  
Agnes Chevalier ◽  
Thomas Hamborg ◽  
Eoin Golden ◽  
Michael King ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Social Isolation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Social Contacts ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundBefriending by volunteers has the potential to reduce the frequent social isolation of patients with schizophrenia and thus improve health outcomes. However, trial-based evidence for its effectiveness is limited.AimsTo conduct a randomised controlled trial of befriending for patients with schizophrenia or related disorders.MethodPatients were randomised to a befriending programme for 1 year or to receive information about social activities only (trial registration: ISRCTN14021839). Outcomes were assessed masked to allocation at the end of the programme; at 12 months and at a 6-month follow-up. The primary outcome was daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis.ResultsA total of 124 patients were randomised (63 intervention, 61 active control) and 92 (74%) were followed up at 1 year. In the intervention group, 49 (78%) met a volunteer at least once and 31 (49%) had more than 12 meetings. At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI −40.7 to 58.5, P = 0.72). There were no significant differences in quality of life, symptoms or self-esteem. However, patients in the intervention group had significantly more social contacts than those in the control group at the end of the 12-month period. This difference held true at the follow-up 6 months later.ConclusionsAlthough no difference was found on the primary outcome, the findings suggest that befriending may have a lasting effect on increasing social contacts. It may be used more widely to reduce the social isolation of patients with schizophrenia.

scholarly journals Intensive versus standard physical rehabilitation therapy in the critically ill (EPICC): a multicentre, parallel-group, randomised controlled trial

Thorax ◽  
2017 ◽  
Vol 73 (3) ◽  
pp. 213-221 ◽  
Author(s):  
Stephen E Wright ◽  
Kirsty Thomas ◽  
Gillian Watson ◽  
Catherine Baker ◽  
Andrew Bryant ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Outcome Data ◽  
Physical Rehabilitation ◽  
Control Group ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Lost To Follow Up

BackgroundEarly physical rehabilitation in the intensive care unit (ICU) has been shown to improve short-term clinical outcomes but long-term benefit has not been proven and the optimum intensity of rehabilitation is not known.MethodsWe conducted a randomised, parallel-group, allocation-concealed, assessor-blinded, controlled trial in patients who had received at least 48 hours of invasive or non-invasive ventilation. Participants were randomised in a 1:1 ratio, stratified by admitting ICU, admission type and level of independence. The intervention group had a target of 90 min physical rehabilitation per day, the control group a target of 30 min per day (both Monday to Friday). The primary outcome was the Physical Component Summary (PCS) measure of SF-36 at 6 months.ResultsWe recruited 308 participants over 34 months: 150 assigned to the intervention and 158 to the control group. The intervention group received a median (IQR) of 161 (67–273) min of physical rehabilitation on ICU compared with 86 (31–139) min in the control group. At 6 months, 62 participants in the intervention group and 54 participants in the control group contributed primary outcome data. In the intervention group, 43 had died, 11 had withdrawn and 34 were lost to follow-up, while in the control group, 56 had died, 5 had withdrawn and 43 were lost to follow-up. There was no difference in the primary outcome at 6 months, mean (SD) PCS 37 (12.2) in the intervention group and 37 (11.3) in the control group.ConclusionsIn this study, ICU-based physical rehabilitation did not appear to improve physical outcomes at 6 months compared with standard physical rehabilitation.Trial registration numberISRCTN 20436833.

scholarly journals Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
S van Wessel ◽  
T Hamerlynck ◽  
V Schutyser ◽  
C Tomassetti ◽  
C Wyns ◽  
...  
Keyword(s):  
Live Birth ◽  
Financial Support ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Fertility Treatment ◽  
Control Group ◽  
Women Of Reproductive Age ◽  
Operative Hysteroscopy ◽  
Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

Sign in / Sign up

Export Citation Format

Share Document