search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intervention
Sponsored by
Nordsjaellands Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, Health-related quality of life, Nutrition, Mental health, Functional capacity, Anthropometry

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Nordsjællands HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control Group

Arm Description

Intervention contains: individual nutritional plan regular contact friendly reminder/informal caregiver and weight dairy.

Standard of care

Outcomes

Primary Outcome Measures

Health-related quality of life
Will be measured using the EQ-5D-5L

Secondary Outcome Measures

Weight
Measured using an electronic scale (TANITA DC 430 SMA, TANITA, Denmark) to the nearest 0.1 kg
Body mass index
Calculated as weight (kg)/height (m2)
Hand grip strength
Measured using handdynanometer
Lower body strength
Measured using 30 second stand chair test
Number of unplanned acute hospitalizations
Obtained from patient files
Number of days in hospital
Obtained from patient files
Number of acute unplanned visits to emergency ward (<6 hours)
Obtained from patient files
Number of contacts to outpatient clinic (visits and phone calls)
Obtained from patient files
Disease specific quality of life
Obtained using COPD Assessment test (CAT). CAT contains 8 items with a scoring range of 0-40. The total score indicate the impact level COPD has on the everyday life ranging from low to very high. A total score of 5 is referred to the upper limit of normal in healthy non-smokers, a total score <10 indicate low impact, 10-20 indicate medium impact, whereas >20 and >30 indicate high and very high impact, respectively.
Mortality
will be obtained from patient files
Fat-free mass
Measured using bioelectrical impedance analysis
Fat mass
Measured using bioelectrical impedance analysis

Full Information

First Posted
April 23, 2021
Last Updated
December 12, 2022
Sponsor
Nordsjaellands Hospital
Collaborators
Rigshospitalet, Denmark, University of Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT04873856
Brief Title
Multidimensional Individualized Nutritional Therapy for Individuals With Severe COPD
Acronym
MINDNUT
Official Title
Multidimensional INDividualized NUTritional Therapy for Individuals With Severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nordsjaellands Hospital
Collaborators
Rigshospitalet, Denmark, University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease, Health-related quality of life, Nutrition, Mental health, Functional capacity, Anthropometry

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention contains: individual nutritional plan regular contact friendly reminder/informal caregiver and weight dairy.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention
Intervention Description
The four dimensions of MINDNUT are described below: Nutritional plan: is conducted in collaboration with the participant based on nutritional registration and information about routines and habits to reach a daily protein target of 1.5 g/kg/day. The nutritional plan is adjusted at the regular contact, and nutritional supplementation will be handed out to the participant. Friendly reminder/informal caregiver: is a friendly reminder that encourage the participant to follow the nutritional plan and to ask for support (a note to hang on the refrigerator). The informal caregiver is a person with close contact to the participant. Regular contacts: The participant will be contacted on regular basis (with an interval of 7-14 days) via phone and besides nutritional plan, this conversation will be used to talk about well-being, compliance and potential side-effects. Weight diary: participants is instructed in keeping a weight diary which include registration of a daily weight.
Primary Outcome Measure Information:
Title
Health-related quality of life
Description
Will be measured using the EQ-5D-5L
Time Frame
1 and 3 months after baseline
Secondary Outcome Measure Information:
Title
Weight
Description
Measured using an electronic scale (TANITA DC 430 SMA, TANITA, Denmark) to the nearest 0.1 kg
Time Frame
1 and 3 months after baseline
Title
Body mass index
Description
Calculated as weight (kg)/height (m2)
Time Frame
1 and 3 months after baseline
Title
Hand grip strength
Description
Measured using handdynanometer
Time Frame
1 and 3 months after baseline
Title
Lower body strength
Description
Measured using 30 second stand chair test
Time Frame
1 and 3 months after baseline
Title
Number of unplanned acute hospitalizations
Description
Obtained from patient files
Time Frame
1 and 3 months after baseline
Title
Number of days in hospital
Description
Obtained from patient files
Time Frame
1 and 3 months after baseline
Title
Number of acute unplanned visits to emergency ward (<6 hours)
Description
Obtained from patient files
Time Frame
1 and 3 months after baseline
Title
Number of contacts to outpatient clinic (visits and phone calls)
Description
Obtained from patient files
Time Frame
up to 3 months after baseline
Title
Disease specific quality of life
Description
Obtained using COPD Assessment test (CAT). CAT contains 8 items with a scoring range of 0-40. The total score indicate the impact level COPD has on the everyday life ranging from low to very high. A total score of 5 is referred to the upper limit of normal in healthy non-smokers, a total score <10 indicate low impact, 10-20 indicate medium impact, whereas >20 and >30 indicate high and very high impact, respectively.
Time Frame
1 and 3 months after baseline
Title
Mortality
Description
will be obtained from patient files
Time Frame
up to 3 months after baseline
Title
Fat-free mass
Description
Measured using bioelectrical impedance analysis
Time Frame
1 and 3 months after baseline
Title
Fat mass
Description
Measured using bioelectrical impedance analysis
Time Frame
1 and 3 months after baseline
Other Pre-specified Outcome Measures:
Title
Total protein intake
Description
Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams
Time Frame
1 and 3 months after baseline
Title
Difference in protein requirement and protein intake
Description
Intake measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams adnd requirements is calculated as 1.5 g/kg/day.
Time Frame
1 and 3 months after baseline
Title
Total energy intake
Description
Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in kalories.
Time Frame
1 and 3 months after baseline
Title
Difference in energy requirement and energy intake
Description
Intake measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in kalories. Requirements calculated as 30 kcal/kg/day if goal is weight maintenance and 45 kcal kg/day if goal is weight gain
Time Frame
1 and 3 months after baseline
Title
Upper arm circumference
Description
Measured using a measuring tape to the nearest 0.1 cm
Time Frame
1 and 3 months after baseline
Title
Hip circumference
Description
Measured using a measuring tape to the nearest 0.1 cm
Time Frame
1 and 3 months after baseline
Title
Waist circumference
Description
Measured using a measuring tape to the nearest 0.1 cm
Time Frame
1 and 3 months after baseline
Title
Number of exacerbations
Description
Obtained from patient files supplemented with self-reported information
Time Frame
1 and 3 months after baseline
Title
Oxygen therapy
Description
Self-reported. The participant is asked if he/she is currently using home oxygen.
Time Frame
1 and 3 months after baseline
Title
Anxiety and depression
Description
Measured using Hospital Anxiety and Depression Scale. The scale contains two subscales to evaluate risk of anxiety and depression. Each subscale contains 7 items with a total score from 0-21. Risk of anxiety and depression are based on a total score ≥8.
Time Frame
1 and 3 months
Title
Physical activity (subjective)
Description
Measured using the physical activity and vial signs questionnaire
Time Frame
1 and 3 months after baseline
Title
Physical activity (objective)
Description
Measured using accelerometers (Activity AX3, Newcastle, United Kingdom)
Time Frame
7 days from 1- months follow-up and 7 days from 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria H Hegelund
Phone
+45 48292778
Email
maria.hein.hegelund.01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte Lindegaard, MD, PhD
Organizational Affiliation
Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital, 3400 Hillerød, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nordsjællands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria H Hegelund
Phone
+45 48292778
Email
maria.hein.hegelund.01@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multidimensional Individualized Nutritional Therapy for Individuals With Severe COPD

We'll reach out to this number within 24 hrs