UndernutritionNCT03211845
Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients
A study testing Nutritional telemonitoring in people with Undernutrition and Aging, run by Wageningen University at 1 site in Netherlands.
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 pilot study are to test the feasibility, acceptability and implementation fidelity of telemonitoring of nutritional parameters in… 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
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 May 2015to 20 Nov 2015
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University and Research
Wageningen, Gelderland, 6700 AA
About this study
Official title: 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.
- Conditions
- Undernutrition, Aging
- Being tested
- Nutritional telemonitoring
- Keywords
- Ehealth, Older adults, Undernutrition, Feasibility study
- 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 group | Role | What they receive |
|---|---|---|
| Nutritional telemonitoring | Experimental | 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. Receives: Other: Nutritional telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (qualitative outcome)
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.
Measured: 12 weeks
Secondary outcomes (8)
Behavioural determinants
Measured by a self-developed questionnaire with statements concerning nutrition and physical activity to be answered on a 5-point likert scale.
Measured: 12 weeks
Diet quality (DHD-index)
Measured by Dutch Healthy Diet index (DHD-index)
Measured: 12 weeks
Nutritional status (MNA)
Measured by Mini Nutritional Assessment
Measured: 12 weeks
Appetite (SNAQ)
Measured by Simplified Nutritional Appetite Questionnaire
Measured: 12 weeks
Body weight (kg)
Measured by weighing scale of the brand A\&D, type UC-411PBT-C
Measured: 12 weeks
Physical functioning (SPPB)
Measured by Short Physical Performance Battery (SPPB)
Measured: 12 weeks
Functional status (KATZ-15)
Measured by KATZ-15
Measured: 12 weeks
Quality of life (SF-36)
Measured by Short-Form 36
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start27 May 2015
- Primary completion20 Nov 2015
- Study completion20 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Lisette de Groot, Professor, Study chair, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211845
- Sponsor's protocol ID
- NL50423.081.14
- Status last verified
- Jul 2017
- First submitted
- 3 Jul 2017
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Feasibility and Potential Impact of Nutritional Telemonitoring in Community Dwelling Elderly People Receiving Home Care
- ClinicalTrials.gov ID
- NCT03211845
- Acronym / sponsor ID
- NL50423.081.14
- Conditions
- Undernutrition, Aging
- Keywords
- Ehealth, Older adults, Undernutrition, Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- 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
- Study start
- 27 May 2015 (actual)
- Primary completion
- 20 Nov 2015 (actual)
- Study completion
- 20 Nov 2015 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional telemonitoring | Experimental | Other: Nutritional telemonitoringNutritional 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Domestic care
- Personal care
- Nursing care
- Individual or group support
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional telemonitoringParticipants 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. | Other | Nutritional telemonitoring |
Primary outcome
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.
8 secondary outcomes
Behavioural determinants
Time frame: 12 weeks
Diet quality (DHD-index)
Time frame: 12 weeks
Nutritional status (MNA)
Time frame: 12 weeks
Appetite (SNAQ)
Time frame: 12 weeks
Body weight (kg)
Time frame: 12 weeks
Physical functioning (SPPB)
Time frame: 12 weeks
Functional status (KATZ-15)
Time frame: 12 weeks
Quality of life (SF-36)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisette de Groot, Professor study chair
Wageningen University and Research
1 site in 1 country: see every site and its status.
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 5 inclusion and 7 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 7 Jul 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?
Feasibility (qualitative outcome) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.