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Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients
This study has been completed.
Sponsor:
Wageningen University
Collaborators:
European Union
Consorci Sanitari de Terrassa
Viveris Technologies SA
STMicroelectronics Grenoble 2 SAS
Sirlan Technologies SAS
Habitat @Sante SARL
Universite Paris 13
Meditecnologia SA
Cybermoor
Telecom Sante
Zorggroep Noordwest-Veluwe
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT03211845
First received: July 3, 2017
Last updated: July 5, 2017
Last verified: July 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Undernutrition Aging | Other: Nutritional telemonitoring |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Prevention |
| Official Title: | Pilot Study to Assess the Feasibility and Potential Impact of Nutritional Telemonitoring in Community Dwelling Elderly People Receiving Home Care |
Further study details as provided by Wageningen University:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
- Diet quality (DHD-index) [ Time Frame: 12 weeks ]Measured by Dutch Healthy Diet index (DHD-index)
- Nutritional status (MNA) [ Time Frame: 12 weeks ]Measured by Mini Nutritional Assessment
- Appetite (SNAQ) [ Time Frame: 12 weeks ]Measured by Simplified Nutritional Appetite Questionnaire
- Body weight (kg) [ Time Frame: 12 weeks ]Measured by weighing scale of the brand A&D, type UC-411PBT-C
- Physical functioning (SPPB) [ Time Frame: 12 weeks ]Measured by Short Physical Performance Battery (SPPB)
- Functional status (KATZ-15) [ Time Frame: 12 weeks ]Measured by KATZ-15
- Quality of life (SF-36) [ Time Frame: 12 weeks ]Measured by Short-Form 36
| Enrollment: | 20 |
| Actual Study Start Date: | May 27, 2015 |
| Study Completion Date: | November 20, 2015 |
| Primary Completion Date: | November 20, 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211845
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211845
Locations
| Netherlands | |
| Wageningen University and Research | |
| Wageningen, Gelderland, Netherlands, 6700 AA | |
Sponsors and Collaborators
Wageningen University
European Union
Consorci Sanitari de Terrassa
Viveris Technologies SA
STMicroelectronics Grenoble 2 SAS
Sirlan Technologies SAS
Habitat @Sante SARL
Universite Paris 13
Meditecnologia SA
Cybermoor
Telecom Sante
Zorggroep Noordwest-Veluwe
Investigators
| Study Chair: | Lisette de Groot, Professor | Wageningen University and Research |
More Information
Additional Information:
| Responsible Party: | Wageningen University |
| ClinicalTrials.gov Identifier: | NCT03211845 History of Changes |
| Other Study ID Numbers: |
NL50423.081.14 |
| Study First Received: | July 3, 2017 |
| Last Updated: | July 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Wageningen University:
|
Ehealth Older adults Undernutrition Feasibility study |
Additional relevant MeSH terms:
|
Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on July 11, 2017