Clinical trial NCT03240094: Feasibility and Effectiveness of Nutritional Telemonitoring in Community-dwelling Elderly.
Official title: PhysioDom Home Dietary Intake Monitoring: Telemonitoring of Nutritional Parameters and Other Outcomes in Community Dwelling Elderly People: a Process and Effect Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Aging
Keywords: Ehealth
Older adults
Undernutrition
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: European Union
name: Consorci Sanitari de Terrassa
name: Viveris Technologies SA
name: STMicroelectronics Grenoble 2 SAS
name: Sirlan Technologies SAS
name: Habitat Health Environment
name: Universite Paris 13
name: Meditecnologia SA
name: Cybermoor Ltd
name: Telecom Sante
name: Zorggroep Noordwest-Veluwe
name: Opella
First posted: 2017-08-04
Enrollment: 213
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 adults.


Eligibility 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
* 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

Primary outcomes:
measure: Nutritional status (MNA)
timeFrame: 6 months
Secondary outcomes:
measure: Behavioural determinant: Knowledge
timeFrame: 6 months
measure: Behavioural determinant: Goalsetting
timeFrame: 6 months
measure: Behavioural determinant: Intention to eat healthy
timeFrame: 6 months
measure: Behavioural determinant: Intention to improve physical activity
timeFrame: 6 months
measure: Behavioural determinant: Self efficacy
timeFrame: 6 months
measure: Behavioural determinant: Perceived behavioural control
timeFrame: 6 months
measure: Behavioural determinants: Attitude
timeFrame: 6 months
measure: Diet quality (DHD-index)
timeFrame: 6 months
measure: Appetite (SNAQ)
timeFrame: 6 months
measure: Body weight (kg)
timeFrame: 6 months
measure: Physical functioning (SPPB)
timeFrame: 6 months
measure: Functional status (KATZ-15)
timeFrame: 6 months
measure: Quality of life (SF-36)
timeFrame: 6 months
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University & Research
Study officials:
affiliation: Wageningen University & Research
name: Lisette de Groot, Professor
role: STUDY_CHAIR
affiliation: Wageningen University & Research
name: Marije van Doorn, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University & Research
name: Jeanne de Vries, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University & Research
name: Annemien Haveman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.