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HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients (HOMEFOOD)

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ClinicalTrials.gov Identifier: NCT03995303
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Alfons Ramel, University of Iceland

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.


Condition or disease Intervention/treatment Phase
Malnutrition Other: NCP and home-delivered meals Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : July 26, 2020
Estimated Study Completion Date : July 26, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NCP and home-delivered meals
Preventing malnutrition with NCP by a registered dietician and home-delivered meals
Other: NCP and home-delivered meals
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. Giving the group free food to fulfill protein-and energy needs.
Other Name: NCP and delivered meals

No Intervention: Current practice
Current practice after discharge from the University Hospital of Iceland.



Primary Outcome Measures :
  1. Weight changes [ Time Frame: Measurement at discharge, baseline ]
    Weight will be measured in kilograms

  2. Weight changes [ Time Frame: Measurement at 12 weeks ]
    Weight will be measured in kilograms

  3. Weight changes [ Time Frame: Measurement at 24 weeks ]
    Weight will be measured in kilograms

  4. Energy intake [ Time Frame: Measurement at discharge, baseline ]
    Energy in kilocalories per 24 hours

  5. Energy intake [ Time Frame: Measurement at 12 weeks ]
    Energy in kilocalories per 24 hours

  6. Energy intake [ Time Frame: Measurement at 24 weeks ]
    Energy in kilocalories per 24 hours

  7. Protein intake [ Time Frame: Measurement at discharge, baseline ]
    Protein intake in g/day

  8. Protein intake [ Time Frame: Measurement at 12 weeks ]
    Protein intake in g/day

  9. Protein intake [ Time Frame: Measurement at 24 weeks ]
    Protein intake in g/day

  10. Fluid intake [ Time Frame: Measurement at discharge, baseline ]
    Fluid intake evaluated in liters per 24 hours

  11. Fluid intake [ Time Frame: Measurement at 12 weeks ]
    Fluid intake evaluated in liters per 24 hours

  12. Fluid intake [ Time Frame: Measurement at 24 weeks ]
    Fluid intake evaluated in liters per 24 hours

  13. Waist circumference [ Time Frame: Measurement at 24 weeks ]
    Measured in centimeters

  14. Upper arm circumference [ Time Frame: Measurement at 24 weeks ]
    Measured in centimeters

  15. calf circumference [ Time Frame: Measurement at 24 weeks ]
    Measured in centimeters

  16. Grip strength [ Time Frame: Measurement at discharge, baseline ]
    Measured in lbs

  17. Grip strength [ Time Frame: Measurement at 12 weeks ]
    Measured in lbs

  18. Grip strength [ Time Frame: Measurement at 24 weeks ]
    Measured in lbs

  19. Five Times Sit to Stand Test [ Time Frame: Measurement at discharge, baseline ]
    Time to stand up 5 times from a chair measured in seconds

  20. Five Times Sit to Stand Test [ Time Frame: Measurement at 12 weeks ]
    Time to stand up 5 times from a chair measured in seconds

  21. Five Times Sit to Stand Test [ Time Frame: Measurement at 24 weeks ]
    Time to stand up 5 times from a chair measured in seconds

  22. Balance test [ Time Frame: Measurement at discharge, baseline ]
    Balance test measured in seconds

  23. Balance test [ Time Frame: Measurement at 12 weeks ]
    Balance test measured in seconds

  24. Balance test [ Time Frame: Measurement at 24 weeks ]
    Balance test measured in seconds

  25. Health Related Quality of Life (HRQL) [ Time Frame: Measurement at discharge, baseline ]
    Measured by HRQL questionnaire wich has 12 domains that cover a range of psychological and physical functions; functional status, vitality, social function, physical pain, emotions, general health, and mental health. The domains are summarized into a single general score which is then converted into a sex- and age specific T-score (T-score norm is 50 ± 10; higher score indicates better HRQL).

  26. Health Related Quality of Life (HRQL) [ Time Frame: Measurement at 12 weeks ]
    Measured by HRQL questionnaire wich has 12 domains that cover a range of psychological and physical functions; functional status, vitality, social function, physical pain, emotions, general health, and mental health. The domains are summarized into a single general score which is then converted into a sex- and age specific T-score (T-score norm is 50 ± 10; higher score indicates better HRQL).

  27. Health Related Quality of Life (HRQL) [ Time Frame: Measurement at 24 weeks ]
    Measured by HRQL questionnaire wich has 12 domains that cover a range of psychological and physical functions; functional status, vitality, social function, physical pain, emotions, general health, and mental health. The domains are summarized into a single general score which is then converted into a sex- and age specific T-score (T-score norm is 50 ± 10; higher score indicates better HRQL).

  28. Height [ Time Frame: Measurement at discharge, baseline ]
    Body height in centimeters

  29. Body weight [ Time Frame: Measurement at discharge, baseline ]
    Body weight in kilograms

  30. Body weight [ Time Frame: Measurement at 12 weeks ]
    Body weight in kilograms

  31. Body weight [ Time Frame: Measurement at 24 weeks ]
    Body weight in kilograms


Secondary Outcome Measures :
  1. Re-hospitalization [ Time Frame: at 12 months from recruitment to trial ]
    Number of participants who were re-hospitalized

  2. Mortality [ Time Frame: at 12 months from recruitment to trial ]
    Number of participants who deceased



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995303


Contacts
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Contact: Ása Þórisdóttir, Ph.D. +3545254835 asavala@hi.is

Locations
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Iceland
Geriatric Unit of Landspitali - University Hospital of Iceland Recruiting
Reykjavík, Non-US, Iceland, 101
Contact: Palmi V Jonsson, MD, FACP    003545431000    palmivj@landspitali.is   
Sponsors and Collaborators
University of Iceland
Investigators
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Principal Investigator: Alfons Ramel, Ph.D. University of Iceland
Principal Investigator: Olof G Geirsdottir, Ph.D. University of Iceland
Principal Investigator: Berglind S Blondal, MSc University of Iceland
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Responsible Party: Alfons Ramel, Professor, University of Iceland
ClinicalTrials.gov Identifier: NCT03995303    
Other Study ID Numbers: UI-2018-HOMEFOOD
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alfons Ramel, University of Iceland:
Malnutrition
Old adults
Home-delivered meals
NCP - Nutrition Care Process
Food
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders