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

Primary Purpose

Undernutrition, Aging

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Nutritional telemonitoring
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Undernutrition focused on measuring Ehealth, Older adults, Undernutrition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wageningen University & Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutritional telemonitoring

Usual care

Arm Description

Participants in the intervention group receive a telemonitoring intervention, 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.

Participants in the control group receive usual care.

Outcomes

Primary Outcome Measures

Nutritional status (MNA)
Measured by Mini Nutritional Assessment

Secondary Outcome Measures

Behavioural determinant: Knowledge
Measured with 11 knowledge statements to be answered by true/false/don't know
Behavioural determinant: Goalsetting
Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.
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.
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.
Behavioural determinant: Self efficacy
Measured by two items to be answered on a 5 point likert scale on a 5-point likert scale.
Behavioural determinant: Perceived behavioural control
Measured by five items to be answered on a 5 point likert scale on a 5-point likert scale.
Behavioural determinants: Attitude
Measured by 14 items to be answered on a 5 point likert scale
Diet quality (DHD-index)
Measured by Dutch Healthy Diet index (DHD-index)
Appetite (SNAQ)
Measured by Simplified Nutritional Appetite Questionnaire
Body weight (kg)
Measured by weighing scale of the brand A&D, type UC-411PBT-C
Physical functioning (SPPB)
Measured by Short Physical Performance Battery (SPPB)
Functional status (KATZ-15)
Measured by KATZ-15
Quality of life (SF-36)
Measured by Short-Form 36

Full Information

First Posted
July 24, 2017
Last Updated
August 3, 2017
Sponsor
Wageningen University
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, Opella
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1. Study Identification

Unique Protocol Identification Number
NCT03240094
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 26, 2016 (Actual)
Primary Completion Date
May 9, 2017 (Actual)
Study Completion Date
May 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University
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, Opella

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition, Aging
Keywords
Ehealth, Older adults, Undernutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritional telemonitoring
Arm Type
Experimental
Arm Description
Participants in the intervention group receive a telemonitoring intervention, 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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants in the control group receive usual care.
Intervention Type
Other
Intervention Name(s)
Nutritional telemonitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nutritional status (MNA)
Description
Measured by Mini Nutritional Assessment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Behavioural determinant: Knowledge
Description
Measured with 11 knowledge statements to be answered by true/false/don't know
Time Frame
6 months
Title
Behavioural determinant: Goalsetting
Description
Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.
Time Frame
6 months
Title
Behavioural determinant: Intention to eat healthy
Description
Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.
Time Frame
6 months
Title
Behavioural determinant: Intention to improve physical activity
Description
Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.
Time Frame
6 months
Title
Behavioural determinant: Self efficacy
Description
Measured by two items to be answered on a 5 point likert scale on a 5-point likert scale.
Time Frame
6 months
Title
Behavioural determinant: Perceived behavioural control
Description
Measured by five items to be answered on a 5 point likert scale on a 5-point likert scale.
Time Frame
6 months
Title
Behavioural determinants: Attitude
Description
Measured by 14 items to be answered on a 5 point likert scale
Time Frame
6 months
Title
Diet quality (DHD-index)
Description
Measured by Dutch Healthy Diet index (DHD-index)
Time Frame
6 months
Title
Appetite (SNAQ)
Description
Measured by Simplified Nutritional Appetite Questionnaire
Time Frame
6 months
Title
Body weight (kg)
Description
Measured by weighing scale of the brand A&D, type UC-411PBT-C
Time Frame
6 months
Title
Physical functioning (SPPB)
Description
Measured by Short Physical Performance Battery (SPPB)
Time Frame
6 months
Title
Functional status (KATZ-15)
Description
Measured by KATZ-15
Time Frame
6 months
Title
Quality of life (SF-36)
Description
Measured by Short-Form 36
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisette de Groot, Professor
Organizational Affiliation
Wageningen University & Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marije van Doorn, MSc
Organizational Affiliation
Wageningen University & Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeanne de Vries, PhD
Organizational Affiliation
Wageningen University & Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annemien Haveman, PhD
Organizational Affiliation
Wageningen University & Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wageningen University & Research
City
Wageningen
ZIP/Postal Code
6700AA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30445922
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.
Results Reference
derived
PubMed Identifier
29759110
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.
Results Reference
derived

Learn more about this trial

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

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