scholarly journals The effectiveness of a family-centred intervention after traumatic brain injury: A pragmatic randomised controlled trial

2021 ◽  
pp. 026921552110103
Author(s):  
Mari S Rasmussen ◽  
Nada Andelic ◽  
Are H Pripp ◽  
Tonje H Nordenmark ◽  
Helene L Soberg

Objectives: To determine the effectiveness of a family-centred intervention for patients with traumatic brain injury and family members. Design: Open-labelled, two-armed randomised controlled trial. Settings: Outpatient clinic and family residences. Participants: Sixty-one patients (33 women) with traumatic brain injury, with mean (SD) age 43.8 (12.2), and 63 family members (33 women), with mean (SD) age 42.6 (11.3), were assign to intervention ( n = 30 families) and control group ( n = 31 families). Intervention: An eight-session single-family intervention to improve individual and family functioning. Outcome measures: Self-reported questionnaires at start-of-treatment, median (IQR) 11.4 (8.4, 15.9) months post-injury, and at two follow-ups, 2.7 (2.3, 3.8) and 9.2 (8.2, 9.9) months after start-of-treatment. Primary outcome measures were the SF-36 Mental Component Summary (MCS) and Caregiver Burden Scale (CGB). Secondary outcome measures were the Family Adaptability and Cohesion Evaluation Scale (FACES) and Quality of Life after Brain Injury Questionnaire (QOLIBRI). Group differences were analysed with linear mixed-model analysis for repeated measurements. Results: No significant between-group differences were found. The intervention group significantly improved on the MCS, the CGB and FACES in the treatment period, whereas the controls did not. The mean (SD) MCS change in the treatment period was 2.4 (1.1) points P = 0.028 in the intervention group. Mean (SE) MCS scores were 47.9 (1.26) and 47.3 (1.27) in the intervention and control group at last follow-up. Conclusions: Receiving an eight-session family intervention, in addition to specialised rehabilitation for the patients, was not superior to rehabilitation at a specialised traumatic brain injury outpatient clinic.

2018 ◽  
Vol 20 (1) ◽  
pp. 1-15 ◽  
Author(s):  
Robyn L. Tate ◽  
Michelle Genders ◽  
Cheryl Soo ◽  
Ulrike Rosenkoetter ◽  
Margaret Dunn ◽  
...  

Introduction: Existing resources to support adolescents with acquired brain injury (ABI) in transition from school to the ‘adult world’ are variable. This study evaluated an intervention using a coaching approach to support adolescents during this transition phase.Method: The study design was a parallel-group randomised controlled trial (RCT). Participants (n= 43) aged 14–19 years were randomised to intervention (n= 21) or no-intervention control (n= 21) conditions. The intervention group received six coaching sessions over an average of 22 weeks. Outcome measures evaluated changes reported by the adolescent (satisfaction, emotional functioning and hope) and their parent (participation, behaviour and support needs).Results: Relative to baseline, there was no significant improvement for those in the intervention group in comparison to the control group on any of the outcome measures.Conclusion: The results of this RCT do not support coaching as an intervention for adolescents with ABI.


2003 ◽  
Vol 6 (3) ◽  
pp. 249-257 ◽  
Author(s):  
M Moursi ◽  
F Mbemba ◽  
S Trèche

AbstractObjective:To assess the effect of the incorporation of amylase in maize-based flours prepared as gruels on the energy intake and growth of Congolese infants.Design:A randomised controlled trial. At 18 weeks of age, infants were randomised into either an intervention group, where they were provided with a maize/soya-based flour that contained amylase, or a control group, where they were provided with a similar flour that did not contain amylase.Setting:Urban borough of Poto-Poto in Brazzaville, The Congo.Subjects:Eighty infants (40 in each group) were randomised into intervention and control groups. Three infants in the intervention group and two controls subsequently dropped out.Results:At 24 weeks, the addition of amylase resulted in a significant increase in energy intake (in kJ kg-1day-1) from gruels (P=0.02) without affecting breast milk consumption. In contrast, total energy intake (in kJ kg-1day-1) did not differ significantly between groups (P=0.08). After adjustment for morbidity and previous growth, infants in the intervention group showed better growth in length during the trial (+0.22 cm month-1;P=0.04), especially between 24 and 31 weeks of age (+0.51 cm month-1;P>0.01). There were no differences in weight velocity between groups.Conclusions:The findings of this study suggest that the consumption of amylase-treated gruels allows an increase in energy intake from these gruels without affecting breast milk consumption but has no impact on total daily energy intake. However, if started after 6 months, it could be effective in preventing faltering of infant linear growth.


2020 ◽  
Author(s):  
C Ni Mhurchu ◽  
Lisa Te Morenga ◽  
R Tupai-Firestone ◽  
J Grey ◽  
Y Jiang ◽  
...  

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: The OL@-OR@ mobile health programme was co-designed with Māori and Pasifika communities in New Zealand, to support healthy lifestyle behaviours. We aimed to determine whether use of the programme improved adherence to health-related guidelines among Māori and Pasifika communities in New Zealand compared with a control group on a waiting list for the programme. Methods: The OL@-OR@ trial was a 12-week, two-arm, cluster-randomised controlled trial. A cluster was defined as any distinct location or setting in New Zealand where people with shared interests or contexts congregated, such as churches, sports clubs, and community groups. Members of a cluster were eligible to participate if they were aged 18 years or older, had regular access to a mobile device or computer, and had regular internet access. Clusters of Māori and of Pasifika (separately) were randomly assigned (1:1) to either the intervention or control condition. The intervention group received the OL@-OR@ mHealth programme (smartphone app and website). The control group received a control version of the app that only collected baseline and outcome data. The primary outcome was self-reported adherence to health-related guidelines, which were measured with a composite health behaviour score (of physical activity, smoking, alcohol intake, and fruit and vegetable intake) at 12 weeks. The secondary outcomes were self-reported adherence to health-related behaviour guidelines at 4 weeks; self-reported bodyweight at 12 weeks; and holistic health and wellbeing status at 12 weeks, in all enrolled individuals in eligible clusters; and user engagement with the app, in individuals allocated to the intervention. Adverse events were not collected. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12617001484336. Findings: Between Jan 24 and Aug 14, 2018, we enrolled 337 Māori participants from 19 clusters and 389 Pasifika participants from 18 clusters (n=726 participants) in the intervention group and 320 Māori participants from 15 clusters and 405 Pasifika participants from 17 clusters (n=725 participants) in the control group. Of these participants, 227 (67%) Māori participants and 347 (89%) Pasifika participants (n=574 participants) in the intervention group and 281 (88%) Māori participants and 369 (91%) Pasifika participants (n=650 participants) in the control group completed the 12-week follow-up and were included in the final analysis. Relative to baseline, adherence to health-related behaviour guidelines increased at 12 weeks in both groups (315 [43%] of 726 participants at baseline to 329 [57%] of 574 participants in the intervention group; 331 [46%] of 725 participants to 369 [57%] of 650 participants in the control group); however, there was no significant difference between intervention and control groups in adherence at 12 weeks (odds ratio [OR] 1·13; 95% CI 0·84–1·52; p=0·42). Furthermore, the proportion of participants adhering to guidelines on physical activity (351 [61%] of 574 intervention group participants vs 407 [63%] of 650 control group participants; OR 1·03, 95% CI 0·73–1·45; p=0·88), smoking (434 [76%] participants vs 501 [77%] participants; 1·12, 0·67–1·87; p=0·66), alcohol consumption (518 [90%] participants vs 596 [92%] participants; 0·73, 0·37–1·44; p=0·36), and fruit and vegetable intake (194 [34%] participants vs 196 [30%] participants; 1·08, 0·79–1·49; p=0·64) did not differ between groups. We found no significant differences between the intervention and control groups in any secondary outcome. 147 (26%) intervention group participants engaged with the OL@-OR@ programme (ie, set at least one behaviour change goal online). Interpretation: The OL@-OR@ mobile health programme did not improve adherence to health-related behaviour guidelines amongst Māori and Pasifika individuals. Funding: Healthier Lives He Oranga Hauora National Science Challenge.


2019 ◽  
Author(s):  
Tuva Moseng ◽  
Hanne Dagfinrud ◽  
Leti van Bodegom-Vos ◽  
Krysia Dziedzic ◽  
Kåre Birger Hagen ◽  
...  

Abstract Background: To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model. Methods: The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group. Results: 284 intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (OR adjusted 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders. Conclusions: The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers.


2020 ◽  
Author(s):  
C Ni Mhurchu ◽  
Lisa Te Morenga ◽  
R Tupai-Firestone ◽  
J Grey ◽  
Y Jiang ◽  
...  

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: The OL@-OR@ mobile health programme was co-designed with Māori and Pasifika communities in New Zealand, to support healthy lifestyle behaviours. We aimed to determine whether use of the programme improved adherence to health-related guidelines among Māori and Pasifika communities in New Zealand compared with a control group on a waiting list for the programme. Methods: The OL@-OR@ trial was a 12-week, two-arm, cluster-randomised controlled trial. A cluster was defined as any distinct location or setting in New Zealand where people with shared interests or contexts congregated, such as churches, sports clubs, and community groups. Members of a cluster were eligible to participate if they were aged 18 years or older, had regular access to a mobile device or computer, and had regular internet access. Clusters of Māori and of Pasifika (separately) were randomly assigned (1:1) to either the intervention or control condition. The intervention group received the OL@-OR@ mHealth programme (smartphone app and website). The control group received a control version of the app that only collected baseline and outcome data. The primary outcome was self-reported adherence to health-related guidelines, which were measured with a composite health behaviour score (of physical activity, smoking, alcohol intake, and fruit and vegetable intake) at 12 weeks. The secondary outcomes were self-reported adherence to health-related behaviour guidelines at 4 weeks; self-reported bodyweight at 12 weeks; and holistic health and wellbeing status at 12 weeks, in all enrolled individuals in eligible clusters; and user engagement with the app, in individuals allocated to the intervention. Adverse events were not collected. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12617001484336. Findings: Between Jan 24 and Aug 14, 2018, we enrolled 337 Māori participants from 19 clusters and 389 Pasifika participants from 18 clusters (n=726 participants) in the intervention group and 320 Māori participants from 15 clusters and 405 Pasifika participants from 17 clusters (n=725 participants) in the control group. Of these participants, 227 (67%) Māori participants and 347 (89%) Pasifika participants (n=574 participants) in the intervention group and 281 (88%) Māori participants and 369 (91%) Pasifika participants (n=650 participants) in the control group completed the 12-week follow-up and were included in the final analysis. Relative to baseline, adherence to health-related behaviour guidelines increased at 12 weeks in both groups (315 [43%] of 726 participants at baseline to 329 [57%] of 574 participants in the intervention group; 331 [46%] of 725 participants to 369 [57%] of 650 participants in the control group); however, there was no significant difference between intervention and control groups in adherence at 12 weeks (odds ratio [OR] 1·13; 95% CI 0·84–1·52; p=0·42). Furthermore, the proportion of participants adhering to guidelines on physical activity (351 [61%] of 574 intervention group participants vs 407 [63%] of 650 control group participants; OR 1·03, 95% CI 0·73–1·45; p=0·88), smoking (434 [76%] participants vs 501 [77%] participants; 1·12, 0·67–1·87; p=0·66), alcohol consumption (518 [90%] participants vs 596 [92%] participants; 0·73, 0·37–1·44; p=0·36), and fruit and vegetable intake (194 [34%] participants vs 196 [30%] participants; 1·08, 0·79–1·49; p=0·64) did not differ between groups. We found no significant differences between the intervention and control groups in any secondary outcome. 147 (26%) intervention group participants engaged with the OL@-OR@ programme (ie, set at least one behaviour change goal online). Interpretation: The OL@-OR@ mobile health programme did not improve adherence to health-related behaviour guidelines amongst Māori and Pasifika individuals. Funding: Healthier Lives He Oranga Hauora National Science Challenge.


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e039767
Author(s):  
Zorry Belchev ◽  
Mary Ellene Boulos ◽  
Julia Rybkina ◽  
Kadeen Johns ◽  
Eliyas Jeffay ◽  
...  

IntroductionIndividuals with moderate-severe traumatic brain injury (m-sTBI) experience progressive brain and behavioural declines in the chronic stages of injury. Longitudinal studies found that a majority of patients with m-sTBI exhibit significant hippocampal atrophy from 5 to 12 months post-injury, associated with decreased cognitive environmental enrichment (EE). Encouragingly, engaging in EE has been shown to lead to neural improvements, suggesting it is a promising avenue for offsetting hippocampal neurodegeneration in m-sTBI. Allocentric spatial navigation (ie, flexible, bird’s eye view approach), is a good candidate for EE in m-sTBI because it is associated with hippocampal activation and reduced ageing-related volume loss. Efficacy of EE requires intensive daily training, prohibitive within most current health delivery systems. The present protocol is a novel, remotely delivered and self-administered intervention designed to harness principles from EE and allocentric spatial navigation to offset hippocampal atrophy and potentially improve hippocampal functions such as navigation and memory for patients with m-sTBI.Methods and analysisEighty-four participants with chronic m-sTBI are being recruited from an urban rehabilitation hospital and randomised into a 16-week intervention (5 hours/week; total: 80 hours) of either targeted spatial navigation or an active control group. The spatial navigation group engages in structured exploration of different cities using Google Street View that includes daily navigation challenges. The active control group watches and answers subjective questions about educational videos. Following a brief orientation, participants remotely self-administer the intervention on their home computer. In addition to feasibility and compliance measures, clinical and experimental cognitive measures as well as MRI scan data are collected pre-intervention and post-intervention to determine behavioural and neural efficacy.Ethics and disseminationEthics approval has been obtained from ethics boards at the University Health Network and University of Toronto. Findings will be presented at academic conferences and submitted to peer-reviewed journals.Trial registration numberVersion 3, ClinicalTrials.gov Registry (NCT04331392).


Author(s):  
Ellahe Mohyadin ◽  
Zohreh Ghorashi ◽  
Zahra Molamomanaei

AbstractBackgroundAnxiety and fear of labor pain has led to elevated cesarean section rate in some countries. This study was conducted to investigate the effect of yoga in pregnancy on anxiety, labor pain and length of labor stages.MethodsThis clinical trial study was performed on 84 nulliparous women who were at least 18 years old and were randomly divided into two groups of yoga and control groups. Pregnancy Yoga Program consisting of 6 60-min training sessions was started every 2 weeks from week 26 of pregnancy and continued until 37 weeks of gestation. Anxiety severity at maternal admission to labor was measured by the Spielbergers State-Trait Anxiety Inventory, and labor pain was measured by Visual Analogue Scale (VAS) at dilatation (4–5 cm) and 2 h after the first measurement. Data were analyzed using Chi-Square and t-test.ResultsIntervention group reported less pain at dilatation (4–5 cm) (p=0.001) and 2 h after the first measurement (p=0.001) than the control group. Stat anxiety was also lower in intervention group than the control group (p=0.003) at the entrance to labor room. Subjects in the control group required more induction compared to intervention group (p=0.003). Women in intervention group experienced shorter duration of the first phase of the labor than the control group (p=0.002). Also, the total duration of two stages of labor was shorter in intervention group than the control group (p=0.003).ConclusionsPracticing yoga during pregnancy may reduce women’s anxiety during labor; shorten labor stages, and lower labor pain.


2021 ◽  
Vol 12 ◽  
pp. 215145932110291
Author(s):  
Atsuko Satoh ◽  
Yukoh Kudoh ◽  
Sangun Lee ◽  
Masumi Saitoh ◽  
Miwa Miura ◽  
...  

Introduction: To evaluate fall-prevention rehabilitative slippers for use by self-caring, independent older adults. Materials and Methods: This assessor-blinded, randomized, and controlled 1-year study included 59 self-caring, independent participants (49 women) who attended day services. The mean age of participants was 84.0 ± 5.3 years. Participants were randomly selected from 8 nursing homes. We tested slippers top-weighted with a lead bead (200, 300, or 400 g). Intervention group participants walked while wearing the slippers for 10-20 min, 1-3 days/week at the day service center. Fall risk was measured using the Berg Balance Scale and the Tinetti Performance-Oriented Mobility Assessment (POMA) before and at 3-month intervals after the intervention/control phase. Results: After 12 months, the intervention group demonstrated significant improvement. Berg Balance and POMA compared to the control group ( p < .05 p < .01, respectively). Mobility scores improved significantly for both measurements in the intervention group before and after ( p < .01), but the control group had significantly lower scores. Discussion: Overall, falls decreased in the intervention group from 10 to 7, and control group falls increased from 9 to 16 ( p = .02). No adverse events related to the intervention were reported. Conclusions: Rehabilitation training slippers may reduce falls in older adults.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 100.3-100
Author(s):  
Y. Wang ◽  
X. Liu ◽  
Y. Shi ◽  
X. Ji ◽  
W. Wang ◽  
...  

Background:Clinical practice guidelines recommend that exercise is an essential component in the self-management of Ankylosing Spondylitis (AS). Attending supervised interventions requiring periodic medical center visits can be burdensome and patients may decline participation, whereas, effective home-based exercise interventions that do not need regular medical center visits are likely to be more accessible and acceptable for patients with AS. Recently, increasing evidences have been accumulated that the wearable devices could facilitate patients with inflammatory arthritis by giving exercise instructions and improving self-efficacy. Therefore, patients with AS may benefit from an effective technology-assisted home-based exercise intervention.Objectives:To investigate the efficacy of a comprehensive technology-assisted home-based exercise intervention on disease activity in patients with AS.Methods:This study was a 16-week assessor-blinded, randomized, waiting-list controlled trial (ChiCTR1900024244). Patients with AS were randomly allocated to the home-based exercise intervention group and the waiting-list control group. A 16-week comprehensive exercise program consisting of a moderate intensity (64%-76% HRmax) aerobic training for 30min on 5 days/week and a functional training for 60min on 3 days/week was given to patients in the intervention group immediately after randomization, with 1.5h training sessions for two consecutive days by a study physical therapist at baseline and Week 8. The aerobic exercise intensity was controlled by a Mio FUSE Wristband with a smartphone application. The functional training consisted of the posture training, range of motion exercises, strength training, stability training and stretching exercises. Patients in control group received standard care during the 16-week follow-up and started to receive the exercise program at Week 16. The primary outcome was ASDAS at Week 16. The secondary outcomes were BASDAI, BASFI, BASMI, ASAS HI, peak oxygen uptake, body composition and muscle endurance tests. The mean difference between groups in change from baseline was analyzed with the analysis of covariance.Results:A total of 54 patients with AS were enrolled (26 in intervention group and 28 in control group) and 46 (85.2%) patients completed the 16-week follow-up. The mean difference of ASDAS between groups in change from baseline to 16-week follow-up was −0.2 (95% CI, −0.4 to 0.003, P = 0.032), and the mean change from baseline was -0.4 (95% CI, -0.5 to -0.2) in the intervention group vs -0.1 (95% CI, -0.3 to 0.01) in the control group, respectively. Significant between-group differences were found between groups for BASDAI (−0.5 [95% CI, −0.9 to −0.2], P = 0.004), BASMI (−0.7 [95% CI, −1.1 to −0.4], P <0.001), BASFI (−0.3 [95% CI, −0.6 to 0.01], P=0.035), peak oxygen uptake (2.7 [95% CI, 0.02 to 5.3] ml/kg/min, P=0.048) and extensor endurance test (17.8 [95% CI, 0.5 to 35.2]s, P=0.044) at Week 16. Between-group differences were detected in ASAS HI (−0.9 [95% CI, −1.7 to −0.1], P=0.030), body fat percentage (−1.0 [95% CI, −2.0 to −0.01] %, P=0.048) and visceral adipose tissue (−4.9 [95% CI, −8.5 to −1.4] cm2, P=0.008) at Week 8, but not at Week 16. No significant between-group differences were detected in the total lean mass, time up and go test and the flexor endurance test during the follow-up.Conclusion:Comprehensive technology-assisted home-based exercise has been shown to have beneficial effects on disease activity, physical function, spinal mobility, aerobic capacity, and body composition as well as in improving fatigue and morning stiffness of patients with AS.References:[1]van der Heijde D, Ramiro S, Landewé R, et al. Ann Rheum Dis 2017;76:978–991.Disclosure of Interests:None declared


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