The main objective of this study is to measure the effects of the monitoring and feedback tool embedded in a Self-management Support Program on physical activity. The secondary objective is to measure the effect on self-efficacy, quality of life and…
ID
Source
Brief title
Condition
- Diabetic complications
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Physical activity measured with a physical activity monitor (PAM).
Secondary outcome
Quality of life, general self-efficacy, exercise self-efficacy and health
status.
Background summary
Physical activity is an important factor for a healthy lifestyle. Although
physical activity can delay complications and decrease the burden of the
disease in chronically ill persons, their level of activity is often far from
optimal. Many interventions have been developed to stimulate physical activity,
with disappointing results. New in this field is the use of technology. Human
persuasion (for example guidance by a practice nurse) can be enhanced by
technological persuasion. Therefore a monitor and feedback tool, consisting of
an accelerometer linked to a smart phone and webserver, has been developed and
tested.
Study objective
The main objective of this study is to measure the effects of the monitoring
and feedback tool embedded in a Self-management Support Program on physical
activity. The secondary objective is to measure the effect on self-efficacy,
quality of life and health status. In addition a process evaluation will be
conducted.
Study design
A three-armed cluster randomised controlled trial will be conducted with 240
patients from 24 general practices. Randomisation level is the practice. The
following conditions will be compared: 1) Tool and Self-management Support
Program; 2) Self-management Support Program; 3) Care as usual. Outcome measures
will be measured at t0 (before the start of the intervention), t1 (after 4-6
months, directly after the intervention) and t2 (3 months after the end of the
intervention).
Intervention
Spread over a period of four to six months patients in condition 1 and 2 have
to visit the practice nurse for 3-4 times for physical activity counselling.
Specific activity goals will be set that are tailored to the individual
patient*s preferences and needs. On top of this, patients in condition 1 will
be instructed to use the monitoring and feedback tool in daily life. Patients
in condition 3 will not be exposed to any intervention.
Study burden and risks
The burden of the intervention is considered without risks. Only patients with
a health status in which the gradual increase of their physical activity level
is justified, will be recruited. Furthermore the questionnaires about quality
of life, self-efficacy and health status are considered without risk.
Duboisdomein 30
Maastricht 6229 GT
NL
Duboisdomein 30
Maastricht 6229 GT
NL
Listed location countries
Age
Inclusion criteria
People diagnosed with COPD or diabetes type 2 who are predominantly treated in primary care and are expected to benefit from more physical activity, will be included. Their age should be 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% / more than 53 mmol/mol 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 1, 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 or participating in another physical activity intervention 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 approached.
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 |
|---|---|
| Other | NL42580..068.12 |
| CCMO | NL42580.068.12 |