NCT05950373

Brief Summary

This project explores whether access to a digital education video can improve the nutritional situation of home-living older adults after being discharged from the hospital.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2025Oct 2026

First Submitted

Initial submission to the registry

July 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

July 11, 2023

Last Update Submit

April 2, 2024

Conditions

Malnutrition

Keywords

Older adultsDiseases-related malnutritionEducational video

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life Using Rand 36 questionaire

    Using Rand 36 questionaire. The data from the SF-36 ordinal subscales will be transformed to a ratio scale using the syntax SF-36 manual and will be presented as the results from each of the eight subscales and the two main scales

    Change in Health related quality of life Using Rand 36 questionaire after 3 months

Secondary Outcomes (7)

  • Body fat

    Change in Body mass index after 3 months.

  • Readmissions to hospital after discharge from the hospital

    Registration of Readmissions 3 months after

  • Muscle strength

    Change in Hand Grip Strength (muscle strength) after 3 months

  • The mid-arm circumferences

    Change in the mid-arm cirumferences after three months.

  • Subcutaneous fat

    Change in Subcutaneous fat after three months.

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

The Intervention group will get access to a six-minute long education video five days after being discharges from the hospital. The video is focusing on protein and energy meals for older adults. The educational film is available via a link on a tablet/ computer or mobile phone. The education video vil only be given one time.

Other: Education video

Control group

NO INTERVENTION

The control group will not be given any intervention.

Interventions

Education videoOTHER

six minute long education video focusing on protein and energy meals for older adults.

Intervention group

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Surgical patients embedded in a regional hospital.
  • Home-living in one of nine selected municipalities.
  • Be able to read and understand Norwegian.
  • Have a consent competence.
  • Have a body mass index \< 24.
  • Have access to a digital solution such as a tablet or phone.

You may not qualify if:

  • Persons given only a liquid diet.
  • Persons in a terminally ill phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monica Christin Hansen

Bodø, 8020, Norway

Location

Related Publications (1)

  • Hansen MC, Uhrenfeldt L, Ingstad K, Pedersen PU. Educational nutritional intervention to prevent loss of health-related quality of life among older adults after a surgical treatment: design of a randomised controlled trial. Trials. 2024 Apr 15;25(1):262. doi: 10.1186/s13063-024-08096-8.

    PMID: 38622729DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Monica Hansen, Master

CONTACT

0047 75517250monica.c.hansen@nord.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 18, 2023

Study Start

January 1, 2025

Primary Completion

November 30, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

April 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)