Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.

Sponsor

Uppsala University (Other)

Overall Status

Completed

CT.gov ID

NCT01057914

Collaborator

Västmanland County Council, Sweden (Other)

671

Enrollment

Locations

Arms

129

Duration (Months)

134.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of nutritional therapy in elderly malnourished patients. The hypothesises are that nutritional supplementation and dietary advice alone or in combination affects mortality, quality of life and health-care consumption after six month of treatment.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition	Dietary Supplement: Nutritional supplementation with a liquid formula Other: Dietary advice Other: Combination of supplement and dietary advice	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

671 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Six Months Treatment With Nutritional Supplements or Dietary Advice, Alone or in Combination on Mortality, Health-related Quality of Life and Health-care Consumption for Elderly Patients at Risk of Malnutrition.

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Nov 1, 2020

Actual Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supplemention	Dietary Supplement: Nutritional supplementation with a liquid formula The patient consumes 400 kcal from a liquid supplementation formula
Experimental: Dietary advice	Other: Dietary advice The patient receives dietary advice for one hour during the hospital stay.
Experimental: Combination treatment	Other: Combination of supplement and dietary advice The patient receives dietary advice for one hour during the hospital stay and consumes 400 kcal from liquid supplementation formula for six month after discharge.
No Intervention: Usual care

Outcome Measures

Primary Outcome Measures

All cause mortality [Six months, one year, three years]

Secondary Outcome Measures

Health-related quality of life [Six months, one year, three years]
Health-care consumption [Six months, one year, three years]
Function in activities in daily life [Six months, one year, three years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥65 years old
Admitted to one of the participating wards during the recruitment period

Exclusion Criteria:

Well-nourished
No consent to participate
Not able to communicate
Not able to understand swedish
Presumed life-expectancy <1 year
Already receiving nutritional therapy including dietary advice, supplements, tube-feeding or parenteral nutrition
Dietary restrictions due to illness or disease inconsistent with the intervention
Impaired cognitive function or dementia
Body mass index ≥35
Living in old peoples homes, sheltered housing, institution, service flats or nursing homes
Participant in a study evaluating differences in 3-year mortality between well-nourished patients, patients at risk of malnutrition and malnourished patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Falu lasarett	Falun	Dalarna	Sweden	79129
2	Mälarsjukhuset in Eskilstuna	Eskilstuna	Sörmland	Sweden	61188
3	Nyköpings lasarett	Nyköping	Sörmland	Sweden	61188
4	Akademiska sjukhuset	Uppsala	Uppland	Sweden	75125
5	Västmanlands sjukhus Västerås	Västerås	Västmanland	Sweden	72189