Multidimensional Individualized Nutritional Therapy for Individuals With Severe COPD

Study Overview
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Brief Summary
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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.

Official Title
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Multidimensional INDividualized NUTritional Therapy for Individuals With Severe Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Dietary Supplement: Intervention


Participation Criteria
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Eligibility Criteria
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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 CHANGE: Undernourished OR at risk of undernutrition (a maximum BMI of 25 kg/m2) determined by Nutritional Risk Screening 2002 or Mini Nutritional Assessment Short Form according to the protocol published in Trials. 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).

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intervention contains: individual nutritional plan regular contact friendly reminder/informal caregiver and weight dairy. | Dietary Supplement: Intervention<br>* 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.<br>|
| No Intervention: Control Group<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | Will be measured using the EQ-5D-5L | 1 and 3 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measured using an electronic scale (TANITA DC 430 SMA, TANITA, Denmark) to the nearest 0.1 kg | 1 and 3 months after baseline | 
| Body mass index | Calculated as weight (kg)/height (m2) | 1 and 3 months after baseline | 
| Hand grip strength | Measured using handdynanometer | 1 and 3 months after baseline | 
| Lower body strength | Measured using 30 second stand chair test | 1 and 3 months after baseline | 
| Number of unplanned acute hospitalizations | Obtained from patient files | 1 and 3 months after baseline | 
| Number of days in hospital | Obtained from patient files | 1 and 3 months after baseline | 
| Number of acute unplanned visits to emergency ward (<6 hours) | Obtained from patient files | 1 and 3 months after baseline | 
| Number of contacts to outpatient clinic (visits and phone calls) | Obtained from patient files | up to 3 months after baseline | 
| 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. | 1 and 3 months after baseline | 
| Mortality | will be obtained from patient files | up to 3 months after baseline | 
| Fat-free mass | Measured using bioelectrical impedance analysis | 1 and 3 months after baseline | 
| Fat mass | Measured using bioelectrical impedance analysis | 1 and 3 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Chronic obstructive pulmonary disease, Health-related quality of life, Mental health, Anthropometry, Functional capacity