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Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211845
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
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
Information provided by (Responsible Party):
Wageningen University

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.

Condition or disease Intervention/treatment Phase
Undernutrition Aging Other: Nutritional telemonitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study to Assess the Feasibility and Potential Impact of Nutritional Telemonitoring in Community Dwelling Elderly People Receiving Home Care
Actual Study Start Date : May 27, 2015
Actual Primary Completion Date : November 20, 2015
Actual Study Completion Date : November 20, 2015

Arm Intervention/treatment
Experimental: Nutritional telemonitoring
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.
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.




Primary Outcome Measures :
  1. Feasibility (qualitative outcome) [ Time Frame: 12 weeks ]
    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 :
  1. Behavioural determinants [ Time Frame: 12 weeks ]
    Measured by a self-developed questionnaire with statements concerning nutrition and physical activity to be answered on a 5-point likert scale.

  2. Diet quality (DHD-index) [ Time Frame: 12 weeks ]
    Measured by Dutch Healthy Diet index (DHD-index)

  3. Nutritional status (MNA) [ Time Frame: 12 weeks ]
    Measured by Mini Nutritional Assessment

  4. Appetite (SNAQ) [ Time Frame: 12 weeks ]
    Measured by Simplified Nutritional Appetite Questionnaire

  5. Body weight (kg) [ Time Frame: 12 weeks ]
    Measured by weighing scale of the brand A&D, type UC-411PBT-C

  6. Physical functioning (SPPB) [ Time Frame: 12 weeks ]
    Measured by Short Physical Performance Battery (SPPB)

  7. Functional status (KATZ-15) [ Time Frame: 12 weeks ]
    Measured by KATZ-15

  8. Quality of life (SF-36) [ Time Frame: 12 weeks ]
    Measured by Short-Form 36



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211845


Locations
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Netherlands
Wageningen University and Research
Wageningen, Gelderland, Netherlands, 6700 AA
Sponsors and Collaborators
Wageningen University
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
Investigators
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Study Chair: Lisette de Groot, Professor Wageningen University and Research
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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT03211845    
Other Study ID Numbers: NL50423.081.14
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wageningen University:
Ehealth
Older adults
Undernutrition
Feasibility study
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders