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It's LiFe! Innovative monitoring and personalised feedback as a self-management tool in disease management programmes for people with COPD and/or type 2 diabetes; a randomised controlled trial

It's LiFe! Innovative monitoring and personalised feedback as a self-management tool in disease management programmes for people with COPD and/or type 2 diabetes; a randomised controlled trial - RCT It's LiFe!

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39684
Enrollment
240
Registered
2013-02-19
Start date
2013-03-21
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (longziekte) type 2 Diabetes (suikerziekte)

Interventions

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 ar

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Physical activity measured with a physical activity monitor (PAM).

Secondary

MeasureTime frame
Quality of life, general self-efficacy, exercise self-efficacy and health status.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)