Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients

July 5, 2017 updated by: Wageningen University

Pilot Study to Assess the Feasibility and Potential Impact of Nutritional Telemonitoring in Community Dwelling Elderly People Receiving Home Care

An optimal nutritional status is essential for healthy ageing. Telemonitoring might contribute to maintaining or improving nutritional status in elderly people.The objectives of this pilot study are to test the feasibility, acceptability and implementation fidelity of telemonitoring of nutritional parameters in community-dwelling older adults; to test the study procedures for effect evaluation; and to determine the likelihood of achieving desired impact on the primary and secondary outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6700 AA
        • Wageningen University and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Having a care referral for at least one of the following types of care:

  • Domestic care
  • Personal care
  • Nursing care
  • Individual or group support

Exclusion Criteria:

  • Severe cognitive impairment (Mini Mental State Examination (MMSE) < 20)
  • Receiving terminal care
  • Expected length of receiving home care < three months
  • Not having a television at home
  • Clients with a visual impairment (not able to watch the television screen)
  • Clients with a physical impairment in such a way, that they are not able to use the telemonitoring system
  • Clients with nursing home care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional telemonitoring
Nutritional telemonitoring including self-measurements of body weight, nutritional status, appetite, diet quality and physical activity. Additionally, participants receive guidance on nutrition and physical activity by means of customized and general television messages and/or if necessary personal guidance by a nurse.
Other: Nutritional telemonitoring
Participants receive a weighing scale, pedometer and television channel in order to perform self-measurements and receive guidance on nutrition and physical activity. Nurses use a website in order to receive telemonitoring measurements and decide about proper follow-up. In case of risk of undernutrition, nurses provide personal advice to optimize nutritional status of the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (qualitative outcome)
Time Frame: 12 weeks
Qualitative outcome, measured using the process indicators acceptability, implementation, dose received, applicability. Data on these process indicators are collected using logbooks, semi-structured interviews, and questionnaires with items to be answered on a 5-point likert scale.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioural determinants
Time Frame: 12 weeks
Measured by a self-developed questionnaire with statements concerning nutrition and physical activity to be answered on a 5-point likert scale.
12 weeks
Diet quality (DHD-index)
Time Frame: 12 weeks
Measured by Dutch Healthy Diet index (DHD-index)
12 weeks
Nutritional status (MNA)
Time Frame: 12 weeks
Measured by Mini Nutritional Assessment
12 weeks
Appetite (SNAQ)
Time Frame: 12 weeks
Measured by Simplified Nutritional Appetite Questionnaire
12 weeks
Body weight (kg)
Time Frame: 12 weeks
Measured by weighing scale of the brand A&D, type UC-411PBT-C
12 weeks
Physical functioning (SPPB)
Time Frame: 12 weeks
Measured by Short Physical Performance Battery (SPPB)
12 weeks
Functional status (KATZ-15)
Time Frame: 12 weeks
Measured by KATZ-15
12 weeks
Quality of life (SF-36)
Time Frame: 12 weeks
Measured by Short-Form 36
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

European Union
Consorci Sanitari de Terrassa
Viveris Technologies SA
STMicroelectronics Grenoble 2 SAS
Sirlan Technologies SAS
Habitat Health Environment
Universite Paris 13
Meditecnologia SA
Cybermoor Ltd
Telecom Sante
Zorggroep Noordwest-Veluwe

Investigators

  • Study Chair: Lisette de Groot, Professor, Wageningen University and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2015

Primary Completion (Actual)

November 20, 2015

Study Completion (Actual)

November 20, 2015

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

July 5, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL50423.081.14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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