Clinical trial NCT03995303: HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients
Official title: HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Malnutrition
Old adults
Home-delivered meals
NCP - Nutrition Care Process
Food
Lead sponsor: University of Iceland
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 106
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Because of short hospital stays, and nutritional status worsening for geriatric patients, time to improve this is limited. It seems necessary to integrate nutritional support after discharge, to prevent the consequences of malnutrition on health and physical capability. This study tests whether nutrition support using NCP (Nutrition Care Process) (1) in combination with delivered meals designed for old adults, improves nutritional status, muscle strength, physical function, quality of life and rehospitalization and mortality rates after discharge, compared to currently used care (2 = control) along with historical data. Participants (N = 200), will be randomized into two groups, the intervention will last 24 weeks. A dietitian (Ph.D. student) visits participants in the intervention group 5 times during the study period. Outcome parameters will be measured before discharge from the hospital, at 12 weeks and at 24 weeks. Data on hospital readmission and mortality will be followed up at 6 months after the intervention.

Condition or disease: Malnutrition Intervention/treatment: NCP by a dietitian and free food constructed to fulfill protein and energy needs for the group.

Detailed description: Malnutrition is common in older people admitted to the hospital and can worsen after discharge. Therefore, it seems necessary to integrate nutritional support not only during the hospital stay but also in the period after discharge. The aim of this Randomized Controlled Trial (RCT) is to test whether nutritional support provided by a dietitian, using Nutrition Care Process in combination with delivered meals designed for the needs of older adults (group 1), improves nutritional status, muscle strength, physical function, quality of life and as a secondary outcome re-hospitalization and/or mortality of geriatric patients with malnutrition risk after discharge compared to currently used standard care (group 2 = control).

Time and work plan:

After 12 months

* Need identification and product ideas ready
* Packaging material ready
* Estimate of the feasibility of meals for old adults
* Allowances from the ethical committee, the data protection committee, the Ph.D. committee of the Faculty of Food Science and Nutrition at the University of Iceland.

After 24 months

* The last participant recruited
* End of intervention

After 36 months

* End of follow up
* Database ready
* First paper submitted

Methods-Intervention

This 24-week randomized controlled trial will randomize the participants (N = 200) to two groups. The dietitian (Ph.D. student) will perform a total of 5 home visits during the study period to participants in the intervention group. Meals will be delivered weekly to the participants. Outcome parameters will be measured just before discharge from the hospital and after 12 weeks and at 24 weeks in the home of the participants. Data on hospital re-admission and mortality will also be followed up at 12 months.

The aim of the intervention is to implement individual dietetic advice and optimize participants' nutritional status by following the Nutritional Care Process\*, involving nutritional assessment, diagnosis, intervention, monitoring, and evaluation. Dietary counseling, motivation, and education will help to maintain participants' body weight, and ensure that energy and protein requirements as well as for other critical nutrients are achieved.

\*The Nutrition Care Process (NCP) reflects the current state of the art in nutrition care and is designed to improve the consistency and quality of individualized care for patients and the predictability of the patient outcomes. It is not intended to standardize nutrition care for each patient, but to establish a standardized process for providing care.

To achieve the aim, the dietitian (Ph.D. student) will meet the participants in the intervention group, six times.

* The day before discharge where baseline measurements will be done,
* 1 week after discharge,
* 3 weeks after discharge,
* 6 weeks after discharge,
* 9 weeks after discharge, and
* 12 weeks after discharge where endpoint measurements will be done. The dietitian (Ph.D. student) will perform an individual nutritional assessment focusing on dietary intake, activity level and weight of each participant, as a basis for developing an individualized nutrition care plan consistent with estimated nutritional requirements and nutritional rehabilitation goals. Total fluid, energy- and protein requirements will be estimated for each patient. To assess dietary intake, the dietitian will perform a dietary history interview at each visit to determine fluid, energy and protein intake of the participant. Strategies for achieving fluid, energy and protein requirements and achieving compliance included dietary counseling with attention to nutritional risk factors, timing, size and frequency of meals, recommendations for nutrient dense foods and drinks, and provision of educational material.

If relevant, the dietitian will:

* initiate the prescription of oral nutritional supplements with high energy and protein density that will be reimbursed by Health Insurance.
* Contact providers of meals-on-wheels to change the meals to high energy and protein dense menu or to mashed/puréed food.
* Recommend use of vitamin D, calcium and other vitamins-minerals considered necessary to achieve optimal nutritional status,
* Invite home care and community nursing staff to participate in home visits to achieve the best possible outcome for the patient by interdisciplinary collaboration.

If considered relevant the participants will receive a short consultation by telephone by the dietitian to give advice and to stimulate compliance to the proposed nutritional care plan in-between the home visits.

The control group will meet the dietitian/staff for baseline, 12 weeks and at the 24-week endpoint measurements. The control group will not receive any dietary counseling or education during the study period which reflects current clinical practice.

The Ph.D. students' contributions A Ph.D. student in clinical nutrition (Berglind Soffía Blondal) will be the project manager of the intervention study on a day-to-day base. The student will be supervised by Prof. Alfons Ramel and Assoc. Prof. Ólöf Guðný Geirsdóttir, both on the Faculty of Food Science and Nutrition. The student will be involved in application work to the ethical committee, screening, conduct of the intervention study, data work and writing of scientific papers.

Ethics The study has been approved by the Ethics Committee of Landspitali- University Hospital of Iceland and informed written consent will be obtained from all participants. The study can only improve the nutritional status of geriatric patients that take part in the intervention groups. The participants in the control group, however, won't get any nutritional interventions and therefore have a greater risk of re-admissions and a worse overall outcome compared to the intervention groups.

Eligibility criteria: Inclusion Criteria:

* Patients of the geriatric units at the University Hospital of Iceland discharging home to independent living
* A score of 20 or above on the Mini-Mental State Evaluation (MMSE) form
* Being at nutritional risk according to the validated nutritional risk screening tool (NRS-2002, score 3+)
* The capability of eating orally

Exclusion Criteria:

* Living at a nursing home
* MMSE score of under 20
* No nutritional risk

Primary outcomes:
measure: Body weight
timeFrame: Measurement at discharge, baseline
measure: Body weight
timeFrame: Measurement at 12 weeks
measure: Body weight
timeFrame: Measurement at 24 weeks
measure: Five Times Sit to Stand Test
timeFrame: Measurement at discharge, baseline
measure: Five Times Sit to Stand Test
timeFrame: Measurement at 12 weeks
measure: Five Times Sit to Stand Test
timeFrame: Measurement at 24 weeks
measure: Balance test
timeFrame: Measurement at discharge, baseline
measure: Balance test
timeFrame: Measurement at 12 weeks
measure: Balance test
timeFrame: Measurement at 24 weeks
measure: Energy intake
timeFrame: Measurement at discharge, baseline
measure: Energy intake
timeFrame: Measurement at 12 weeks
measure: Energy intake
timeFrame: Measurement at 24 weeks
measure: Protein intake
timeFrame: Measurement at 12 weeks
measure: Protein intake
timeFrame: Measurement at discharge, baseline
measure: Protein intake
timeFrame: Measurement at 24 weeks
measure: Fluid intake
timeFrame: Measurement at discharge, baseline
measure: Fluid intake
timeFrame: Measurement at 12 weeks
measure: Fluid intake
timeFrame: Measurement at 24 weeks
measure: Upper arm circumference
timeFrame: Measurement at discharge, baseline
measure: Upper arm circumference
timeFrame: Measurement at 24 weeks
measure: Waist circumference
timeFrame: Measurement at discharge, baseline
measure: Waist circumference
timeFrame: Measurement at 24 weeks
measure: calf circumference
timeFrame: Measurement at discharge, baseline
measure: calf circumference
timeFrame: Measurement at 24 weeks
measure: lean body mass
timeFrame: Measurement at discharge, baseline
measure: lean body mass
timeFrame: Measurement at 24 weeks
measure: Grip strength
timeFrame: Measurement at discharge, baseline
measure: Grip strength
timeFrame: Measurement at 12 weeks
measure: Grip strength
timeFrame: Measurement at 24 weeks
measure: Health Related Quality of Life (HRQL)
timeFrame: Measurement at discharge, baseline
measure: Health Related Quality of Life (HRQL)
timeFrame: Measurement at 12 weeks
measure: Health Related Quality of Life (HRQL)
timeFrame: Measurement at 24 weeks
measure: Depression
timeFrame: Measurement at discharge, baseline
measure: Depression
timeFrame: Measurement at 24 weeks
measure: Cognitive function
timeFrame: Measurement at discharge, baseline
measure: Cognitive function
timeFrame: Measurement at 24 weeks
measure: Nutrition status
timeFrame: Measurement at discharge, baseline.
measure: Nutrition status
timeFrame: Measurement at 24 weeks
Secondary outcomes:
measure: Re-hospitalization
timeFrame: at 12 months from recruitment to trial
measure: Mortality
timeFrame: at 12 months from recruitment to trial
Other outcomes:
Locations:
city: Reykjavík
country: Iceland
facility: Geriatric Unit of Landspitali - University Hospital of Iceland
state: Non-US
Study officials:
affiliation: University of Iceland
name: Alfons Ramel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iceland
name: Olof G Geirsdottir, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iceland
name: Berglind S Blondal, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blondal BS, Geirsdottir OG, Beck AM, Halldorsson TI, Jonsson PV, Sveinsdottir K, Ramel A. HOMEFOOD randomized trial-beneficial effects of 6-month nutrition therapy on body weight and physical function in older adults at risk for malnutrition after hospital discharge. Eur J Clin Nutr. 2023 Jan;77(1):45-54. doi: 10.1038/s41430-022-01195-2. Epub 2022 Aug 26.