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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nutritional status (MNA)
Time Frame: 6 months
Measured by Mini Nutritional Assessment
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wageningen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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