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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| University of Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Intervention contains:
|
|
| Control Group | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | Will be measured using the EQ-5D-5L | 1 and 3 months after baseline |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Total protein intake | Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams | 1 and 3 months after baseline |
| Difference in protein requirement and protein intake | Intake measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams adnd requirements is calculated as 1.5 g/kg/day. |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Birgitte Lindegaard, MD, PhD | Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital, 3400 Hillerød, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordsjællands Hospital | Hillerød | 3400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41612405 | Derived | Hegelund MH, Ritz C, Olsen MF, Molgaard C, Nielsen TL, Jensen AV, Soborg C, Braagaard L, Krogh-Madsen R, Lindegaard B, Faurholt-Jepsen D. Individualized nutritional care including adherence support improves health-related quality of life in individuals with severe chronic obstructive pulmonary disease: a randomized controlled trial. Health Qual Life Outcomes. 2026 Jan 30;24(1):23. doi: 10.1186/s12955-026-02482-3. | |
| 36747276 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| 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 |
| 1 and 3 months after baseline |
| Total energy intake | Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in kalories. | 1 and 3 months after baseline |
| Difference in energy requirement and energy intake | 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 | 1 and 3 months after baseline |
| Upper arm circumference | Measured using a measuring tape to the nearest 0.1 cm | 1 and 3 months after baseline |
| Hip circumference | Measured using a measuring tape to the nearest 0.1 cm | 1 and 3 months after baseline |
| Waist circumference | Measured using a measuring tape to the nearest 0.1 cm | 1 and 3 months after baseline |
| Number of exacerbations | Obtained from patient files supplemented with self-reported information | 1 and 3 months after baseline |
| Oxygen therapy | Self-reported. The participant is asked if he/she is currently using home oxygen. | 1 and 3 months after baseline |
| Anxiety and depression | 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. | 1 and 3 months |
| Physical activity (subjective) | Measured using the physical activity and vial signs questionnaire | 1 and 3 months after baseline |
| Physical activity (objective) | Measured using accelerometers (Activity AX3, Newcastle, United Kingdom) | 7 days from 1- months follow-up and 7 days from 3 months follow-up |
| Derived |
| Hegelund MH, Ritz C, Nielsen TL, Olsen MF, Soborg C, Braagaard L, Molgaard C, Krogh-Madsen R, Lindegaard B, Faurholt-Jepsen D. Multidimensional individualized nutritional therapy for individuals with severe chronic obstructive pulmonary disease: study protocol for a registry-based randomized controlled trial. Trials. 2023 Feb 6;24(1):86. doi: 10.1186/s13063-023-07099-1. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |