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UndernutritionNCT03240094

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

A study testing Nutritional telemonitoring in people with Undernutrition and Aging, run by Wageningen University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Undernutrition, Aging
What is being tested?
Nutritional telemonitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
1 siteNetherlands
Study dates
26 Feb 2016to 9 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Wageningen University & Research

    Wageningen, 6700AA

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Nutritional telemonitoring
Keywords
Ehealth, Older adults, Undernutrition
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional telemonitoringOther

    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.

Study groups in NCT03240094
Study groupRoleWhat they receive
Nutritional telemonitoringExperimentalParticipants 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.
Receives: Other: Nutritional telemonitoring
Usual careNo interventionParticipants in the control group receive usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nutritional status (MNA)

    Measured by Mini Nutritional Assessment

    Measured: 6 months

Secondary outcomes (13)

  1. Behavioural determinant: Knowledge

    Measured with 11 knowledge statements to be answered by true/false/don't know

    Measured: 6 months

  2. Behavioural determinant: Goalsetting

    Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.

    Measured: 6 months

  3. Behavioural determinant: Intention to eat healthy

    Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.

    Measured: 6 months

  4. Behavioural determinant: Intention to improve physical activity

    Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.

    Measured: 6 months

  5. Behavioural determinant: Self efficacy

    Measured by two items to be answered on a 5 point likert scale on a 5-point likert scale.

    Measured: 6 months

  6. Behavioural determinant: Perceived behavioural control

    Measured by five items to be answered on a 5 point likert scale on a 5-point likert scale.

    Measured: 6 months

  7. Behavioural determinants: Attitude

    Measured by 14 items to be answered on a 5 point likert scale

    Measured: 6 months

  8. Diet quality (DHD-index)

    Measured by Dutch Healthy Diet index (DHD-index)

    Measured: 6 months

  9. Appetite (SNAQ)

    Measured by Simplified Nutritional Appetite Questionnaire

    Measured: 6 months

  10. Body weight (kg)

    Measured by weighing scale of the brand A\&D, type UC-411PBT-C

    Measured: 6 months

  11. Physical functioning (SPPB)

    Measured by Short Physical Performance Battery (SPPB)

    Measured: 6 months

  12. Functional status (KATZ-15)

    Measured by KATZ-15

    Measured: 6 months

  13. Quality of life (SF-36)

    Measured by Short-Form 36

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2017
  2. Study start26 Feb 2016
  3. Primary completion9 May 2017
  4. Study completion9 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03240094
Sponsor's protocol ID
NL53619.081.15
Status last verified
Jul 2017
First submitted
24 Jul 2017
Last updated
4 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van Doorn-van Atten MN, Haveman-Nies A, Pilichowski P, Roca R, de Vries JHM, de Groot CPGM. Telemonitoring to improve nutritional status in community-dwelling elderly: design and methods for process and effect evaluation of a non-randomized controlled trial. BMC Geriatr. 2018 Nov 16;18(1):284. doi: 10.1186/s12877-018-0973-2.

    PubMed 30445922

  • van Doorn-van Atten MN, Haveman-Nies A, van Bakel MM, Ferry M, Franco M, de Groot LCPGM, de Vries JHM. Effects of a multi-component nutritional telemonitoring intervention on nutritional status, diet quality, physical functioning and quality of life of community-dwelling older adults. Br J Nutr. 2018 May;119(10):1185-1194. doi: 10.1017/S0007114518000843.

    PubMed 29759110

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional telemonitoring in people with Undernutrition and Aging, run by Wageningen University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutritional status (MNA) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03240094, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.

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