NCT04160819

Brief Summary

To investigate the effects of an individualized nutritional intervention programs (iNIPs) on nutritional status and readmission rate in older adults with pneumonia during hospitalization and 3 and 6 months after discharge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

November 7, 2019

Last Update Submit

November 13, 2019

Conditions

Keywords

nutritional interventionmalnutritionrespiratory disease

Outcome Measures

Primary Outcomes (1)

  • nutritional status

    Mini-Nutritional Assessment short-form scores;MNA-SF scores ranging within 0-7, 8-11, and 12-14 indicate malnutrition, risk of malnutrition, and normal nutritional status, respectively.

    up to 6 months of intervention

Study Arms (2)

individualized nutritional intervention programs (iNIPs)

EXPERIMENTAL

Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs. Anthropometry (i.e., body mass index, limb circumference, and subcutaneous fat thickness), blood parameters (i.e., albumin and total lymphocyte count), hospital stay, Mini-Nutritional Assessment-Short Form (MNA-SF) score, target daily calorie intake, total calorie intake adherence rate, and three-major-nutrient intake were assessed during hospitalization and 3 and 6 months after discharge. Both groups received regular follow-up through phone calls. Furthermore, the rate of readmission resulting from pneumonia was recorded after discharge.

Other: Assigned Interventions

standard care (SC) group

NO INTERVENTION

SC group was only provided standard nutritional supplements according to the Kaohsiung Chang Gung Memorial Hospital Nutrition Department, and patients' family members were not provided dietary advice.

Interventions

Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs.

Also known as: The SC group was only provided standard nutritional supplements , and patients' family members were not provided dietary advice.
individualized nutritional intervention programs (iNIPs)

Eligibility Criteria

Age66 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Primary diagnosis of pneumonia by a physician
  • Age more than 65 years
  • Malnutrition status indicated by body mass index (BMI) \<18.5 kg/m2 or Mini-Nutritional Assessment-Short Form (MNA-SF) score≤7

You may not qualify if:

  • Renal insufficiency (glomerular filtration rate \[GFR\] \<60 mL/min/1.73 m2 or GFR staging of G3b-G5)
  • Cancer
  • Hospital stay \<7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pei-Hsin Yang

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

PneumoniaMalnutritionRespiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
investigator

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 13, 2019

Study Start

March 1, 2017

Primary Completion

May 24, 2018

Study Completion

May 24, 2018

Last Updated

November 14, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Currently in the submission stage, and then share with other researchers after publication.

Locations