To test the technical performance of the monitoring and feedback tool in a *real life* situation. To test the usability, acceptance and user satisfaction of the tool. To test how care givers (practice nurses and general practitioners) and patients…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes: technical performance, usability, acceptance and user
satisfaction.
Secondary outcome
Secondary outcomes: physical activity, goal attainment, quality of life and
self-efficacy.
Background summary
Before effects of the innovative monitoring and feedback tool It*s LiFe! and
the Self-management Support Program can be evaluated in a randomized controlled
trial, a pilot study will be conducted to test the use of the tool embedded in
primary care. With the results of this pilot study, both the tool and the SSP
will be improved.
Study objective
To test the technical performance of the monitoring and feedback tool in a
*real life* situation. To test the usability, acceptance and user satisfaction
of the tool. To test how care givers (practice nurses and general
practitioners) and patients experience the Self-management Support Program. To
get a first idea about the effectiveness of the tool and to obtain information
about the tested parameters for the sample size calculation of the RCT.
Study design
The study is a 3 months feasibility study in which a mixture of qualitative and
quantitative measurements will be applied.
Intervention
The intervention will be to wear the tool for 3 months. In which the activity
pattern of the participant will be measured and made visible on the mobile
phone. The phone will give feedback and will activate sessions in which the
participants have to answer questions and construct an 'activity plan'. During
this three months they will be supported by their practice nurse in three
consultations of 20 minutes each. The practice nurse is able to see the
activity pattern of the participants during the months.
Study burden and risks
Patients will visit their GP practice (in Wijlre and another practice (to be
announced) three times and during three months they are asked to wear the tool
during the day. After every consultation the participants will be interviewed
by a researcher, during the interviews the participants will be asked about
usability, acceptance and user satisfaction of the tool. In addition,
participants will be asked about their experiences with the Self-management
Support Plan. At baseline and at the end of the intervention participants will
be asked to fill out questionnaires about quality of life, self efficacy and
user satisfaction.
Only patients with a health status in which the gradually increasing of their
physical activity level is justified, will be recruited. Furthermore, goals
will be set in cooperation with the practice nurse. They will be realistic and
tailored to the individual preferences and needs of each patient. So the burden
of the intervention is beneficial to the participant and the intervention is
considered without risks.
Postbus 616
6200 MD Maastricht
NL
Postbus 616
6200 MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
Diagnosed with COPD or Diabetes type 2 treated in primary care.
Age below 70 and above 40.
Additional inclusion criteria for the diabetes group are a recent (no longer than a year ago) HbA1c concentration of more than 7% and a body mass index of more than 25kg/m2.
For the COPD group the following additional inclusion criteria apply: a clinical diagnosis of COPD according to the GOLD-criteria stage 2 and 3 (post bronchodilator FEV1/IVC <= 70% and FEV1 between 30 and 80% of the predicted value); at least six weeks respiratory stable and on a stable drug regimen.
Exclusion criteria
Patients with complex coexisting medical conditions with a low survival rate, severe psychiatric illness or chronic disorders or diseases that seriously influence the ability to be physically active (e.g. amputation, paralysis, claudication intermittens) and those being primarily treated by a medical specialist, as well as patients with insufficient mastery of the Dutch language will be excluded.
Furthermore, patients who do not own a computer with internet connection at home and therefore can*t receive a mail will be excluded. Since the practice nurses select patients from the medical information system, they will decide which patients will be included.
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 | NL39198.068.12 |