To study the effectiveness of the PhysioDom HDIM intervention in maintaining or improving nutritional status and quality of life. Furthermore, the effects on behavioural determinants, appetite, dietary intake, weight, physical activity, and physical…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ondervoeding en gezondheid van (kwetsbare) ouderen in het algemeen.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters of the effect study are:
- Change in MNA score (nutritional status) after six months of intervention.
- Change in SF36 score (quality of life) after six months of intervention
Secondary outcome
The secondary objectives of the effect study are listed below and are
corresponding with the subsequent levels of outcomes as shown in the logic
model in Figure 1 of the research protocol.
On the participant level:
- To perform a process evaluation including the feasibility, acceptability and
implementation fidelity of the PhysioDom HDIM intervention (including
feasibility of telemonitoring of blood pressure) (outputs).
- To study the effects of the PhysioDom HDIM intervention on behavioural
determinants of dietary intake and physical activity (initial objectives).
- To study the effects of the PhysioDom HDIM intervention on dietary intake and
physical activity (intermediate objectives).
- To study the effects of the PhysioDom HDIM intervention on nutritional
parameters (weight, appetite), and physical functioning (long term objectives).
- To study the cost effectiveness of the PhysioDom HDIM intervention (overall
aim).
On the health care professional/organizational level:
- To perform a process evaluation among involved health care professionals and
technicians including the usability, feasibility, acceptability and
implementation fidelity of the Physiodom HDIM intervention (outputs, initial
objectives, intermediate objectives).
Background summary
Governments and care organizations are increasingly turning towards the use of
Ehealth to improve health or support health care. Studies have shown that
Ehealth can contribute to improving health in patients with chronic diseases
like CVD and diabetes. It is also known that (frail) elderly in general can
benefit from Ehealth applications. With regard to healthy ageing, a good
nutritional status is essential. However, the percentage of undernutrition
among community dwelling elderly ranges from eleven to 35 percent, with the
highest prevalence observed among elderly home care clients. Ehealth might
contribute to maintaining or improving nutritional status in elderly people.
However, there is no scientific base for this yet. In this research project, we
will employ a telemonitoring system called *PhysioDom Home Dietary Intake
Monitoring (HDIM)* to monitor nutritional and other parameters in community
dwelling elderly receiving home care. The first step in this research project
comprises pilot testing of this telemonitoring system, which will take place in
the summer of 2015. The second step is a large-scale effect study, taking place
from January 2016. This research protocol comprises only the effect study.
Study objective
To study the effectiveness of the PhysioDom HDIM intervention in maintaining or
improving nutritional status and quality of life. Furthermore, the effects on
behavioural determinants, appetite, dietary intake, weight, physical activity,
and physical functioning are studied. Finally, a process evaluation and
cost-effectiveness evaluation are carried out.
Study design
The effect study will have a duration of ninemonths, employing a
quasi-experimental design with 3 (control group) to 4 (intervention group)
effect measurements.
Intervention
The PhysioDom HDIM intervention consists of a telemonitoring system which will
be employed by participants at home to perform self-measurements of weight,
appetite, nutritional status, dietary intake (primary objective of
telemonitoring), physical activity (secondary objective), and blood pressure
(tertiary objective, optional for a selection of participants). Outcomes of
self-measurements will be displayed on the participant*s TV and will be send to
the district nurse. She will receive alerts when results go beyond a predefined
threshold. The telemonitoring system will be embedded in usual care: when a
district nurse receives an alert, she will provide follow-up according to the
care procedures and protocols which apply to the care organizations, which can
include a care referral to another health care professional. The participants
in the control group receive usual care.
Study burden and risks
Participants will be visited three (control group) to four (intervention group)
times for measurement of the study outcomes. Visits will take place at the
participant*s home and will take between half an hour and two hours, depending
on the questions and procedures included at the different measurement moments.
Furthermore, participants are asked to fill out a paper questionnaire three
(control group) to four (intervention group) times, which will take 20-60
minutes for each questionnaire. Measurements are not invasive; the burden of
the measurements can be considered as minimal. The intervention activities
include a weekly check of the PhysioDom HDIM TV channel, weekly measurements of
weight, measurements of appetite, nutritional status and diet quality (once
every three months), wearing a pedometer for one week per month and monthly
measurement of blood pressure (not for every participant). The risks associated
with participation can be considered negligible, because of the nature of the
intervention (monitoring and coaching) and the fact that this intervention is
complementary to regular home care. Besides a financial and/or material reward,
it is estimated that participants will benefit from the intervention: through
frequent monitoring of nutritional parameters there is an early detection of
deterioration, followed by timely and tailored follow-up by the care
organization.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible for participation in this study, individuals should be aged 65 or over, and must receive one or more of the following types of care:
-Domestic care
-Personal care
-Nursing care
-Individual or group support (including persons receiving informal care or living in a sheltered accommodation or service flat).
Exclusion criteria
-Severe cognitive impairment (Mini Mental State Examination < 20)
-Receiving terminal care
-Expected length of receiving care < 12 months
-Clients who are bedridden or bound to a wheelchair
-Clients with intramural care
-Not being able to watch television
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53619.081.15 |