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

Completed

• Conditions: 10012653; type 2 Diabetes (suikerziekte); Chronic Obstructive Pulmonary Disease (longziekte); 10037454

• Registration Number: NL-OMON39684
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Physical activity measured with a physical activity monitor (PAM). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Quality of life, general self-efficacy, exercise self-efficacy and health<br /><br>status. </p><br>