Feasibility and Effectiveness of Nutritional Telemonitoring in Community-dwelling Elderly.

August 3, 2017 updated by: Wageningen University

PhysioDom Home Dietary Intake Monitoring: Telemonitoring of Nutritional Parameters and Other Outcomes in Community Dwelling Elderly People: a Process and Effect Study.

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 effect study are to test the feasibility and effectiveness of telemonitoring of nutritional parameters in community-dwelling older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

213

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
      • Wageningen, Netherlands, 6700AA
        • Wageningen University & 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
  • Living in a sheltered home or service flat

Exclusion Criteria:

  • Severe cognitive impairment (Mini Mental State Examination (MMSE) < 20)
  • Receiving terminal care
  • 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional telemonitoring
Participants in the intervention group receive a telemonitoring intervention, 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.
No Intervention: Usual care
Participants in the control group receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status (MNA)
Time Frame: 6 months
Measured by Mini Nutritional Assessment
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioural determinant: Knowledge
Time Frame: 6 months
Measured with 11 knowledge statements to be answered by true/false/don't know
6 months
Behavioural determinant: Goalsetting
Time Frame: 6 months
Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.
6 months
Behavioural determinant: Intention to eat healthy
Time Frame: 6 months
Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.
6 months
Behavioural determinant: Intention to improve physical activity
Time Frame: 6 months
Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.
6 months
Behavioural determinant: Self efficacy
Time Frame: 6 months
Measured by two items to be answered on a 5 point likert scale on a 5-point likert scale.
6 months
Behavioural determinant: Perceived behavioural control
Time Frame: 6 months
Measured by five items to be answered on a 5 point likert scale on a 5-point likert scale.
6 months
Behavioural determinants: Attitude
Time Frame: 6 months
Measured by 14 items to be answered on a 5 point likert scale
6 months
Diet quality (DHD-index)
Time Frame: 6 months
Measured by Dutch Healthy Diet index (DHD-index)
6 months
Appetite (SNAQ)
Time Frame: 6 months
Measured by Simplified Nutritional Appetite Questionnaire
6 months
Body weight (kg)
Time Frame: 6 months
Measured by weighing scale of the brand A&D, type UC-411PBT-C
6 months
Physical functioning (SPPB)
Time Frame: 6 months
Measured by Short Physical Performance Battery (SPPB)
6 months
Functional status (KATZ-15)
Time Frame: 6 months
Measured by KATZ-15
6 months
Quality of life (SF-36)
Time Frame: 6 months
Measured by Short-Form 36
6 months

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
Opella

Investigators

  • Study Chair: Lisette de Groot, Professor, Wageningen University & Research
  • Principal Investigator: Marije van Doorn, MSc, Wageningen University & Research
  • Principal Investigator: Jeanne de Vries, PhD, Wageningen University & Research
  • Principal Investigator: Annemien Haveman, PhD, Wageningen University & Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 26, 2016

Primary Completion (Actual)

May 9, 2017

Study Completion (Actual)

May 9, 2017

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 4, 2017

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL53619.081.15

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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