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Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients

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, Feasibility study

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

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

Sites / Locations

  • Wageningen University and Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutritional telemonitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Behavioural determinants
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)
Measured by Dutch Healthy Diet index (DHD-index)
Nutritional status (MNA)
Measured by Mini Nutritional Assessment
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 3, 2017
Last Updated
July 5, 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
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1. Study Identification

Unique Protocol Identification Number
NCT03211845
Brief Title
Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients
Official Title
Pilot Study to Assess the Feasibility and Potential Impact of Nutritional Telemonitoring in Community Dwelling Elderly People Receiving Home Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 27, 2015 (Actual)
Primary Completion Date
November 20, 2015 (Actual)
Study Completion Date
November 20, 2015 (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

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 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.

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, Feasibility study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

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

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisette de Groot, Professor
Organizational Affiliation
Wageningen University and Research
Official's Role
Study Chair
Facility Information:
Facility Name
Wageningen University and Research
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6700 AA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients

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