Family caregiver grief and depression outcomes from the ENABLE III randomized controlled trial.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 48-48
Author(s):  
J Nicholas Dionne-Odom ◽  
Andres Azuero ◽  
Kathleen Lyons ◽  
Jay Hull ◽  
Tor Tosteson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Advanced Cancer ◽  
Effect Size ◽  
Controlled Trial ◽  
Group Effect ◽  
Early Group ◽  
Randomized Controlled ◽  
Care Recipients ◽  
After Care ◽  
Delayed Group

48 Background: Little is known whether early palliative care (PC) support for family caregivers (FCGs) impacts grief and depression after care recipients die. We conducted a randomized controlled trial (RCT) of a nurse-led, phone-based concurrent PC intervention for FCGs delivered at the time of care recipients’ advanced cancer diagnosis (early group) or 12 weeks later (delayed group). We hypothesized that grief and depression scores would be lower for early compared to delayed group FCGs. Methods: Early vs. delayed RCT (10/2010-9/2013) of 123 FCGs of community dwelling persons with advanced cancer in a rural, New Hampshire NCI-designated comprehensive cancer center and affiliated outreach clinics and a Vermont VA medical center receiving a multicomponent intervention (ENABLE [Educate, Nurture, Advise, Before Life Ends]) consisting of 3 weekly sessions, monthly follow-up, and a bereavement call. FCGs of persons dying during the study period completed the Center for Epidemiological Study-Depression scale (CESD) and the Prigerson Inventory of Complicated Grief-Short Form (PG13) 8-12 weeks after care recipients’ deaths. Generalized estimating equations were used to compute group means, standard deviations, and between-group effect size differences. Results: For care recipients who died (n = 70), 44 FCGs (early: n = 19; delayed: n = 25) completed after-death questionnaires. Mean depression scores (CESD) for the early group was 14.6 (SD = 10.7) and for the delayed group was 17.6 (SD = 11.8). Mean grief scores (PG13) for the early group was 22.7 (SD = 4.9) and for the delayed group was 24.9 (SD = 6.9). Between-group effect size differences were not statistically significant (CESD: d = -.27, p = .38; PG13: d = -.36, p = .24). Conclusions: Though statistically insignificant, the magnitude of the observed between-group differences for depression was small and for grief was medium. Considering the small sample size and the delayed group’s mean depression score surpassing the clinical cutoff (CESD score > 16), the clinical relevance of these findings cannot be ruled out. Future upstream FCG PC interventions initiated long before end of life should continue to examine intervention effects on FCG after-death outcomes. Clinical trial information: NCT01245621.

The impact of life review on depression in older adults: a randomized controlled trial

2010 ◽  
Vol 22 (4) ◽  
pp. 572-581 ◽  
Author(s):  
Anne Margriet Pot ◽  
Ernst T. Bohlmeijer ◽  
Simone Onrust ◽  
Anne-Sophie Melenhorst ◽  
Marjolein Veerbeek ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Effect Size ◽  
Comparison Group ◽  
Controlled Trial ◽  
Life Review ◽  
Group Effect ◽  
Randomized Controlled ◽  
The Impact

ABSTRACTBackground: We developed an indicated preventive life-review course, “Looking for Meaning”, based on the assumption that reminiscence styles influence coping with depressive symptoms. This study describes the impact of this course in a pragmatic randomized controlled trial.Methods: Inclusion criteria were >50 years, a score of 5 or higher on the Center for Epidemiological Studies Depression Scale (CES-D), and no depressive disorder or psychotropic or psychological treatment. Participants were randomized and stratified by gender: the experimental group (N = 83) was offered the course and the comparison group (N = 88) a movie. There were three measurements: pre-treatment, post-treatment and 6 months after post-treatment. Depressive symptoms constituted the primary outcome. Secondary outcomes were anxiety symptoms, satisfaction with life, mastery and reminiscence styles. All analyses were conducted according to the intention-to-treat principle. Missing values were replaced by regression imputation.Results: The course reduced depressive symptoms, a decrease that was retained during follow-up. A significant between-group effect size was found (d = 0.58). There was also a reduction in symptoms of anxiety; however, the comparison group showed the same reduction, resulting in a small between-group effect size. Gender and level of depressive symptoms were found to be prognostic factors for the change in depressive symptoms; age was not. Post hoc analyses showed significant between-group effect sizes for females and those with a score above the cut-off of the CES-D.Conclusion: The course “Looking for Meaning” can be recommended for people aged over 50 years, females and older adults with a clinically relevant level of depressive symptoms (above cut-off) in particular.

scholarly journals Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

2021 ◽  
Vol 18 (14) ◽  
pp. 7510
Author(s):  
Guillermo García Pérez de Sevilla ◽  
Olga Barceló Guido ◽  
María de la Paz De la Cruz ◽  
Ascensión Blanco Fernández ◽  
Lidia B. Alejo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nutrition Intervention ◽  
Sitting Time ◽  
Post Intervention ◽  
University Employees ◽  
Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

scholarly journals Results Are Similar Two Years After Acute or Delayed Anterior Cruciate Ligament Reconstruction. A Randomized Controlled Trial

2017 ◽  
Vol 5 (5_suppl5) ◽  
pp. 2325967117S0017
Author(s):  
Karl Eriksson ◽  
Christoffer von Essen ◽  
Björn Barenius
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Endpoint ◽  
Pivot Shift ◽  
Controlled Trial ◽  
Acl Injury ◽  
Activity Level ◽  
Randomized Controlled ◽  
Delayed Group ◽  
The Mean

Objectives: Acute ACLR has been avoided since the 1990’s due to reports of postoperative stiffness. But are these risks still valid with modern arthroscopic techniques? The aim of this randomized controlled trial was to assess the impact of the time between injury and reconstruction on the outcome after ACLR. Our hypothesis was that acute ACLR with semitendinosus graft can be performed safely. Methods: The primary endpoint was ROM at three months after surgery. A power calculation revealed the need for 64 patients to detect a ROM difference of 5 degrees between the groups (5% significance level). 70 patients with a high recreational activity level (Tegner ≥6) who presented with an acute ACL injury were randomized to an acute reconstruction within 8 days from the injury or delayed reconstruction (after normalized ROM) 6-10 weeks after the injury. Fixation was with Endobutton in femur and a metallic interference screw in tibia. The rehabilitation was performed at the same physiotherapy center for all patients. Follow up assessment was performed by a physiotherapist not involved with the rehabilitation. The follow up at 24 months included ROM, Lachman, instrumented laxity with Rolimeter, pivot shift, one leg hop index, Biodex, IKDC, KOOS, Lysholm and Tegner Activity level, and a VAS question regarding knee function and the knee function’s effect on activity level. Results: Seventy percent of the patients were males, mean age at the time of surgery was 27 years (18 -41) and the median pre-injury Tegner level was 9 (6-10) with no differences between the groups. 64 (91%) patients were assessed at three months with no difference according to the primary endpoint. Median Tegner level was restored to pre-injury levels in both groups after one year, and did not change between one and two years. 63 (90%) patients were available for the 2-year follow up. There was one graft rupture and one contralateral ACL injury in both groups. There was additional surgery in 15% of the acute patients and in 31% in the delayed (n.s.). The mean instrumented laxity was 1.8 mm in the acute and 2.0 in the delayed group. There were no positive pivot shift in the acute group and 6 patients with grade 1 or not possible to perform in the delayed group (p=0.039). IKDC revealed no significant differences between the groups. Lysholm score was 87 in both groups. KOOS values showed no significant difference between the groups. VAS response to the question “How is your knee working on a scale from 0-100? (100 = best)” was 81 in the acute and 71 in the delayed group (p=0.1) and “How does your knee affect your activity level? (100 = no affection)” the mean score was 75 in the acute and 67 in the delayed group (p=0.3). Functional strength (one leg hop index >90%) was 85% in the acute and 67% in the delayed group (n.s). Conclusion: We found no increased risk of arthrofibrosis after acute ACLR. Good results can be achieved at two years regardless of ROM and swelling in the acute stage.

scholarly journals The Effect of Proprioceptive Neuromuscular Facilitation on Joint Position Sense: A Systematic Review

2020 ◽  
Vol 29 (4) ◽  
pp. 488-497 ◽  
Author(s):  
Hiroshi Takasaki ◽  
Yu Okubo ◽  
Shun Okuyama
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Methodological Quality ◽  
Controlled Trial ◽  
Position Sense ◽  
Joint Position Sense ◽  
Joint Position ◽  
Healthy Individuals ◽  
Randomized Controlled ◽  
Proprioceptive Neuromuscular Facilitation

Context: Accurate joint position sense (JPS) is necessary for effective motor learning and high performance in activities that require fine motor control. Proprioceptive neuromuscular facilitation (PNF) can be a promising intervention. Objective: To examine existing peer-reviewed original studies that have investigated the effect of PNF techniques on the JPS in terms of the methodological quality, PNF techniques, outcomes, and participant characteristics. Evidence Acquisition: A systematic literature search was performed using PubMed, EMBASE, MEDLINE, CINAHL, SocINDEX, Scopus, and Cochrane Library from inception to January 2018. The following inclusion criteria were used: (1) assessment of the JPS; (2) peer-reviewed original studies with a randomized controlled trial or quasi-randomized controlled trial design; (3) participants with musculoskeletal disorders or healthy individuals (ie, neither animal studies nor those involving neurological problems); and (4) no cointervention with PNF, except for warm-up procedures. The methodological quality was assessed using PEDro scale and 5 additional criteria. Effect size (η2) was calculated where a positive value indicated an increased JPS after PNF as compared with other approaches including the wait-and-see method. Evidence Synthesis: Nine studies were examined for their methodological quality, and only one study scored >6 on the PEDro scale. Positive and large effect size (η2 > .14) was detected in 2 studies where JPS of the knee with contract-relax and replication techniques was assessed in healthy individuals. However, the methodological quality of these studies was poor (PEDro scores of 3 and ≤5 in the total quality score out of 16, respectively). Conclusions: The current study did not find multiple studies with high methodological quality and similar PNF techniques, outcomes, and characteristics of participants. More high-quality studies are required to achieve a comprehensive understanding of the effect of PNF on the JPS.

Pilot randomized controlled trial of a symptom cluster intervention in advanced cancer

2018 ◽  
Vol 28 (1) ◽  
pp. 76-84 ◽  
Author(s):  
Sharla M. Wells-Di Gregorio ◽  
Donald R. Marks ◽  
Joseph DeCola ◽  
Juan Peng ◽  
Danielle Probst ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Symptom Cluster ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial
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