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

Aging Clinical Trial

Official title:

PhysioDom Home Dietary Intake Monitoring: Telemonitoring of Nutritional Parameters and Other Outcomes in Community Dwelling Elderly People: a Process and Effect Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240094
• Other study ID #: NL53619.081.15
• Status: Completed
• Phase: N/A
• First received: July 24, 2017
• Last updated: August 3, 2017
• Start date: February 26, 2016
• Est. completion date: May 9, 2017

Study information

• Verified date: July 2017
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• 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 effect study are to test the feasibility and effectiveness of telemonitoring of nutritional parameters in community-dwelling older adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• 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

• 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

Related Conditions & MeSH terms

• Aging
• Malnutrition
• Undernutrition

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 & Research	Wageningen

Sponsors (13)

Lead Sponsor	Collaborator
Wageningen University	Consorci Sanitari de Terrassa, Cybermoor, European Union, Habitat @Sante SARL, Meditecnologia SA, Opella, 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	Nutritional status (MNA)	Measured by Mini Nutritional Assessment	6 months
Secondary	Behavioural determinant: Knowledge	Measured with 11 knowledge statements to be answered by true/false/don't know	6 months
Secondary	Behavioural determinant: Goalsetting	Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Behavioural determinant: Self efficacy	Measured by two items to be answered on a 5 point likert scale on a 5-point likert scale.	6 months
Secondary	Behavioural determinant: Perceived behavioural control	Measured by five items to be answered on a 5 point likert scale on a 5-point likert scale.	6 months
Secondary	Behavioural determinants: Attitude	Measured by 14 items to be answered on a 5 point likert scale	6 months
Secondary	Diet quality (DHD-index)	Measured by Dutch Healthy Diet index (DHD-index)	6 months
Secondary	Appetite (SNAQ)	Measured by Simplified Nutritional Appetite Questionnaire	6 months
Secondary	Body weight (kg)	Measured by weighing scale of the brand A&D, type UC-411PBT-C	6 months
Secondary	Physical functioning (SPPB)	Measured by Short Physical Performance Battery (SPPB)	6 months
Secondary	Functional status (KATZ-15)	Measured by KATZ-15	6 months
Secondary	Quality of life (SF-36)	Measured by Short-Form 36	6 months

External Links

•   Project's official website