Trials / Completed
CompletedNCT04873856
Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD
Multidimensional INDividualized NUTritional Therapy for Individuals with Severe Chronic Obstructive Pulmonary Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- Nordsjaellands Hospital · Academic / Other
- Sex
- All
- Age
- 35 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Intervention | 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. |
Timeline
- Start date
- 2021-05-21
- Primary completion
- 2023-06-14
- Completion
- 2023-06-14
- First posted
- 2021-05-05
- Last updated
- 2024-11-18
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04873856. Inclusion in this directory is not an endorsement.