NCT03211845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

July 3, 2017

Last Update Submit

July 5, 2017

Conditions

UndernutritionAging

Keywords

EhealthOlder adultsUndernutritionFeasibility study

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (8)

  • Behavioural determinants

    12 weeks

  • Diet quality (DHD-index)

    12 weeks

  • Nutritional status (MNA)

    12 weeks

  • Appetite (SNAQ)

    12 weeks

  • Body weight (kg)

    12 weeks

  • +3 more secondary outcomes

Study Arms (1)

Nutritional telemonitoring

EXPERIMENTAL

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

Interventions

Nutritional telemonitoringOTHER

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.

Nutritional telemonitoring

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Having a care referral for at least one of the following types of care:
  • Domestic care
  • Personal care
  • Nursing care
  • Individual or group support

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University and Research

Wageningen, Gelderland, 6700 AA, Netherlands

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Lisette de Groot, Professor

    Wageningen University and Research

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 7, 2017

Study Start

May 27, 2015

Primary Completion

November 20, 2015

Study Completion

November 20, 2015

Last Updated

July 7, 2017

Record last verified: 2017-07

Locations

NL(1)