scholarly journals Design of the DYNAMO study: a multi-center randomized controlled trial to investigate the effect of pre-thickened oral nutritional supplements in nursing home residents with dysphagia and malnutrition (risk)

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Viviënne A. L. Huppertz ◽  
Nick van Wijk ◽  
Laura W. J. Baijens ◽  
Lisette C. P. G. M. de Groot ◽  
Ruud J. G. Halfens ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Body Weight ◽  
Nursing Home ◽  
Nursing Home Residents ◽  
Nutritional Supplements ◽  
Nutritional Intake ◽  
Nutritional Care ◽  
Randomized Controlled ◽  
Oral Nutritional Supplements

Abstract Background Oropharyngeal Dysphagia (OD) and malnutrition are frequently reported conditions in nursing home residents, and are often interrelated. Best care for dysphagic residents with, or at risk of, malnutrition should target adequate nutritional intake and the safety and efficacy of swallowing. The effect of oral nutritional supplements (ONS) suitable for nursing home residents with concurrent OD and malnutrition (risk) on nutritional status has not been investigated before. The current study aims to investigate the effect of daily use of a range of pre-thickened ONS on the body weight of nursing home residents with OD and malnutrition (risk) compared to standard OD and nutritional care. Methods / design The DYNAMO study is a randomized, controlled, multi-center, open label trial with two parallel groups. Study participants will be recruited in nursing homes of several care organizations in the south of the Netherlands. Study duration is 12 weeks. Residents in the control group will receive standard OD and nutritional care, and residents in the test group will receive standard OD and nutritional care with extra daily supplementation of pre-thickened ONS. The main outcome parameter is the difference in body weight change between the control and test groups. An a priori estimation of the required sample size per group (control / test) totals 78. Other outcome parameters are differences in: nutritional intake, health-related quality of life, OD-specific quality of life, activities of daily living, vital signs, and blood nutrient and metabolite levels. Discussion Regular ONS could address the nutritional needs of nursing home residents with malnutrition (risk), but might be too thin and unsafe for residents with OD. Pre-thickened ONS is suitable for residents with OD. It offers the advantage of being a ready-to-use amylase-resistant product available in several consistencies which are able to increase swallowing efficacy and safety. The DYNAMO study is the first to investigate the effects of pre-thickened ONS on nutritional status in nursing home residents with concurrent OD and malnutrition (risk). Trial registration Netherlands Trial Register (NTR): NTR NL7898. Registered 24 July 2019, https://www.trialregister.nl/trial/7898

scholarly journals A tablet-based intervention for activating nursing home residents with dementia: results from a cluster-randomized controlled trial

2021 ◽  
pp. 1-13
Author(s):  
Julie L. O’Sullivan ◽  
Sonia Lech ◽  
Paul Gellert ◽  
Ulrike Grittner ◽  
Jan-Niklas Voigt-Antons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Nursing Homes ◽  
Psychotropic Medication ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Objectives: To investigate global and momentary effects of a tablet-based non-pharmacological intervention for nursing home residents living with dementia. Design: Cluster-randomized controlled trial. Setting: Ten nursing homes in Germany were randomly allocated to the tablet-based intervention (TBI, 5 units) or conventional activity sessions (CAS, 5 units). Participants: N = 162 residents with dementia. Intervention: Participants received regular TBI (n = 80) with stimulating activities developed to engage people with dementia or CAS (n = 82) for 8 weeks. Measurements: Apathy Evaluation Scale (AES-I, primary outcome), Quality of Life in Alzheimer’s Disease scale, QUALIDEM scale, Neuropsychiatric Inventory, Geriatric Depression Scale, and psychotropic medication (secondary outcomes). Momentary quality of life was assessed before and after each activity session. Participants and staff were blinded until the collection of baseline data was completed. Data were analyzed with linear mixed-effects models. Results: Levels of apathy decreased slightly in both groups (mean decrease in AES-I of .61 points, 95% CI −3.54, 2.33 for TBI and .36 points, 95% CI −3.27, 2.55 for CAS). Group difference in change of apathy was not statistically significant (β = .25; 95% CI 3.89, 4.38, p = .91). This corresponds to a standardized effect size (Cohen’s d) of .02. A reduction of psychotropic medication was found for TBI compared to CAS. Further analyses revealed a post-intervention improvement in QUALIDEM scores across both groups and short-term improvements of momentary quality of life in the CAS group. Conclusions: Our findings suggest that interventions involving tailored activities have a beneficial impact on global and momentary quality of life in nursing home residents with dementia. Although we found no clear advantage of TBI compared to CAS, tablet computers can support delivery of non-pharmacological interventions in nursing homes and facilitate regular assessments of fluctuating momentary states.

Effect of oral nutritional supplements with or without nutritional counselling on mortality, treatment tolerance and quality of life in head-and-neck cancer patients receiving (chemo)radiotherapy: a systematic review and meta-analysis

2020 ◽  
pp. 1-18 ◽  
Author(s):  
Arthur T. Mello ◽  
Dayanne S. Borges ◽  
Luana P. de Lima ◽  
Júlia Pessini ◽  
Pedro V. Kammer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Body Weight ◽  
Adverse Effects ◽  
Functional Status ◽  
Nutritional Supplements ◽  
Risk Of Bias ◽  
Nutritional Counselling ◽  
Oral Nutritional Supplements ◽  
Treatment Tolerance

Abstract Oral nutritional supplements are widely recommended to head-and-neck cancer patients undergoing anti-cancer treatment; however, their effects on the outcomes of most importance to patients are unclear. This study aimed to systematically review the evidence of effect of oral nutritional supplements on mortality, treatment tolerance, quality of life, functional status, body weight and adverse effects. We searched PubMed, Embase, CENTRAL, LILACS, Web of Science, CINAHL, two trial registry platforms, three sources of grey literature and reference lists of included studies. We assessed the risk of bias using the revised Cochrane risk-of-bias tool (RoB 2), and certainty of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. We used random-effects models with Hartung–Knapp correction for the meta-analyses. We included fifteen trials, of which five were ongoing or unpublished, providing evidence in four comparisons. We found very low to low certainty evidence for the effect of oral nutritional supplements on mortality, treatment tolerance, quality of life, functional status and adverse effects. When compared with nutritional counselling alone, nutritional counselling plus oral nutritional supplements probably increased body weight slightly. We also found adverse events relating to supplements use such as nausea, vomiting and feeling of fullness. Possible increases in mortality, treatment tolerance and quality of life besides a possible decrease in functional status are worthy of further investigation. Future research could attempt to address the clinical importance of a probable increase in body weight. Possible adverse effects of the use of oral nutritional supplements should not be overlooked.

511 DO ORAL NUTRITIONAL SUPPLEMENTS IMPROVE QUALITY OF LIFE IN THE FRAIL ELDERLY- A SYSTEMATIC REVIEW

2021 ◽  
Vol 50 (Supplement_2) ◽  
pp. ii14-ii18
Author(s):  
C Ryan ◽  
I Hynd
Keyword(s):  
Quality Of Life ◽  
Physical Exercise ◽  
Elderly Patients ◽  
Frail Elderly ◽  
Nursing Home Residents ◽  
Nutritional Supplements ◽  
Elderly Adult ◽  
Oral Nutritional Supplements ◽  
The Impact

Abstract Background Oral nutritional supplements (ONS) are regularly used in older frail adults to help reduced oral intake, recovery from acute illness and weight gain. As, many frailer patients have limited life expectancies the priority for treatment should be improving quality of life (QoL). We set out to find if ONS increase QoL in the frail elderly adult. Method We searched Embase, Medline and OVID databases for using terms for ONS, frail older adults and QoL. The two authors independently reviewed all papers with any dispute was resolved by discussion. Each paper was then reviewed by both authors to extract data and determine bias before collation. Results The search returned 516 papers. Each paper was briefly reviewed to check for relevance leaving 65 papers for detailed review of which 8 papers were included. Two systematic reviews were included. One was unable to draw conclusions from the 3 papers (out of 17) that included QoL as the graded evidence was too poor. The other showed no impact on QoL (in the 2 out of 12 papers that included QoL) in patients post hip fracture receiving ONS. One paper interviewed frail elderly patients about the perceived benefits of their ONS. Nursing home residents perceived that ONS improved their ability to see family which was inferred as improving QoL. Three papers assessed ONS in conjunction with physical exercise. Two showed an improvement in quality of life in the ONS group despite controls also receiving a physical exercise programme. Two papers assessed the impact of ONS on patients discharged from hospital and those chronically unwell- neither showed any difference in QoL. Discussion Quality of life has been a neglected area of study when assessing the impact of ONS on frail elderly patients. When used in conjunction with physical exercise it seems to have a positive effect.

Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10098-10098 ◽  
Author(s):  
Paolo Pedrazzoli ◽  
Emanuele Cereda ◽  
Silvia Cappello ◽  
Sara Colombo ◽  
Catherine Klersy ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Body Weight ◽  
Systemic Treatment ◽  
Nutritional Supplements ◽  
Calorie Intake ◽  
Nutritional Counseling ◽  
Oral Nutritional Supplements ◽  
Anti Cancer ◽  
Treatment Tolerance

10098 Background: The benefit of systematic use of oral nutritional supplements (ONS) in addition to nutritional counseling in head and neck cancer (HNC) patients undergoing radiotherapy (RT) has not still been properly assessed. Methods: In a single-center, randomized, pragmatic, parallel-group controlled trial (ClinicalTrials.gov: NCT02055833; February 2014 - August 2016), 159 newly diagnosed HNC patients suitable for to RT regardless of previous surgery and induction chemotherapy were randomly assigned to nutritional counseling in combination with omega-3 enriched ONS (N = 78) or without ONS (N = 81) from the start of RT and continuing for up to 3 months after its end. The primary endpoint was the change in body weight at the end of RT. Secondary endpoints included changes in protein-calorie intake, muscle strength, body composition and quality of life (EORTC-QLQ-C30) over the study time points and anti-cancer treatment tolerance. Results: In patients in whom all the variables could be assessed, counseling plus ONS (N = 67) resulted in smaller loss of body weight than nutritional counseling alone (N = 69; mean difference, 1.6 kg [95%CI, 0.5 to 2.7]; P = 0.006). Imputation of missing outcomes provided consistent findings. In the ONS-supplemented group, higher protein-calorie intake and improvement in quality of life over time were also observed (P < 0.001 for all). The use of ONS reduced the need for changes in scheduled anti-cancer treatments (i.e. for RT and/or systemic treatment dose reduction or complete suspension, HR = 0.40 [95%CI, 0.18 to 0.91], P = 0.029). Nine patients reported gastrointestinal intolerance to ONS. Conclusions: In HNC patients undergoing RT or RT plus systemic treatment, and receiving nutritional counseling, weight loss could not be completely prevented, but the use of ONS resulted in better weight maintenance, increased protein-calorie intake, improved quality of life and better anti-cancer treatment tolerance. Clinical trial information: NCT02055833.

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