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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03211845
Other study ID # NL50423.081.14
Secondary ID
Status Completed
Phase N/A
First received July 3, 2017
Last updated July 5, 2017
Start date May 27, 2015
Est. completion date November 20, 2015

Study information

Verified date July 2017
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 20, 2015
Est. primary completion date November 20, 2015
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Netherlands Wageningen University and Research Wageningen Gelderland

Sponsors (12)

Lead Sponsor Collaborator
Wageningen University Consorci Sanitari de Terrassa, Cybermoor, European Union, Habitat @Sante SARL, Meditecnologia SA, Sirlan Technologies SAS, STMicroelectronics Grenoble 2 SAS, Telecom Sante, Universite Paris 13, Viveris Technologies SA, Zorggroep Noordwest-Veluwe

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 weeks
Secondary Behavioural determinants Measured by a self-developed questionnaire with statements concerning nutrition and physical activity to be answered on a 5-point likert scale. 12 weeks
Secondary Diet quality (DHD-index) Measured by Dutch Healthy Diet index (DHD-index) 12 weeks
Secondary Nutritional status (MNA) Measured by Mini Nutritional Assessment 12 weeks
Secondary Appetite (SNAQ) Measured by Simplified Nutritional Appetite Questionnaire 12 weeks
Secondary Body weight (kg) Measured by weighing scale of the brand A&D, type UC-411PBT-C 12 weeks
Secondary Physical functioning (SPPB) Measured by Short Physical Performance Battery (SPPB) 12 weeks
Secondary Functional status (KATZ-15) Measured by KATZ-15 12 weeks
Secondary Quality of life (SF-36) Measured by Short-Form 36 12 weeks
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