Multidimensional Individualized Nutritional Therapy for Individuals With Severe COPD (MINDNUT)

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    120
  • sponsor
    Nordsjaellands Hospital
Updated on 21 March 2022

Summary

Individuals with severe chronic pulmonary disease often life isolated with a high burden of symptoms. Nutritional risk and low quality of life are common, and both associated with increased societal cost and poor prognosis. COPD is a complex and progressive disease with changing clinical states that influences nutritional status and quality of life in different ways. The primary aim is to improve quality of life for individuals with severe COPD.

120 individuals are recruited from the outpatient clinic at Nordsjællands Hospital in Denmark to a randomized controlled trial with two parallel groups (intervention and control). The intervention will last for 3 months comprising four elements including nutritional plan, regular contact, informal caregiver/friendly reminder and a weight dairy.

We expect that the intervention will improve quality of life, nutritional status and prognosis.

Details
Condition Chronic Obstructive Pulmonary Disease
Treatment Intervention
Clinical Study IdentifierNCT04873856
SponsorNordsjaellands Hospital
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥ 35 years
Severe COPD defined as GOLD grade 2 group B or D OR GOLD grade 3 and 4 group ABCD
Able to eat orally
Live in own home
Speak Danish or English
Undernourished OR at risk of undernutrition defined as BMI ≤ 21 kg/m2 if < 70 years and BMI <22 kg/m2 if ≥70 years OR BMI 21-25 kg/m2 plus nutritional risk (nutritional risk screening score ≥3) if <70 years and BMI 22-25 kg/m2 plus nutritional risk if ≥70 years
Stable phase

Exclusion Criteria

Active solid cancer" defined as cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months or hematological cancer that is not in complete remission
Unable to sign informed consent e.g. due to severe dementia
Severe chronic renal failure defined as estimated glomerular filtration rate < 30 mL/min./1.73 m2 (ICD-10 codes N18.4 and N18.5
Severe alcohol abuse (ICD-10 codes F10.2 and K70.x)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note