Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Dietary Supplement: Intervention
- Registration Number
- NCT04873856
- Lead Sponsor
- Nordsjaellands Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
- ≥ 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Intervention Intervention contains: 1. individual nutritional plan 2. regular contact 3. friendly reminder/informal caregiver and 4. weight dairy.
- Primary Outcome Measures
Name Time Method Health-related quality of life 1 and 3 months after baseline Will be measured using the EQ-5D-5L
- Secondary Outcome Measures
Name Time Method Number of unplanned acute hospitalizations 1 and 3 months after baseline Obtained from patient files
Number of days in hospital 1 and 3 months after baseline Obtained from patient files
Mortality up to 3 months after baseline will be obtained from patient files
Weight 1 and 3 months after baseline Measured using an electronic scale (TANITA DC 430 SMA, TANITA, Denmark) to the nearest 0.1 kg
Number of contacts to outpatient clinic (visits and phone calls) up to 3 months after baseline Obtained from patient files
Fat-free mass 1 and 3 months after baseline Measured using bioelectrical impedance analysis
Body mass index 1 and 3 months after baseline Calculated as weight (kg)/height (m2)
Hand grip strength 1 and 3 months after baseline Measured using handdynanometer
Fat mass 1 and 3 months after baseline Measured using bioelectrical impedance analysis
Lower body strength 1 and 3 months after baseline Measured using 30 second stand chair test
Number of acute unplanned visits to emergency ward (<6 hours) 1 and 3 months after baseline Obtained from patient files
Disease specific quality of life 1 and 3 months after baseline 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.
Trial Locations
- Locations (1)
Nordsjællands Hospital
🇩🇰Hillerød, Denmark