- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02229019
The Southampton Mealtime Assistance Roll-out Trial (SMART)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Hampshire
-
Southampton, Hampshire, Storbritannien, SO21 3BX
- Southampton General Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients over the age of 70 years admitted to one of the wards under study
Exclusion Criteria:
- Patients with active bowel pathology
- Patients in the terminal phase of their life
- Patients who are artificially fed (parenterally or enterally)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Volunteer mealtime assistance
Trained volunteers will provide mealtime assistance to older hospital inpatients at one mealtime each weekday.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Feasibility and acceptability of volunteer mealtime assistants in different hospital departments
Tidsram: 16 months
|
Is it feasible to recruit and sustain sufficient volunteers to provide mealtime assistance across a large hospital trust? Are these volunteers acceptable to patients, relatives, and staff? This will be determined by recording the number of volunteers recruited, trained and assessed and by recording their activity, in numbers of mealtimes assisted per week and duration of volunteering. If a volunteer discontinues their role, the reasons will be identified for this. Acceptability will be assessed through qualitative methods- interviews with patients and relatives and focus groups with nursing staff and volunteers. |
16 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Changes in food choice and dietary intake before and after the introduction of volunteer mealtime assistants
Tidsram: 16 months
|
The food choices and dietary intake of patients on the wards under study will be determined twice prior to the introduction of the volunteers and twice after their introduction.
This will take place at the mealtime where the volunteers are assisting.
The weight of meals served is portion controlled by the hospital caterers to within 10% of the stated weight.
Therefore, using these stated weights and by measuring the leftover weight of food, we will calculate each patient's dietary intake at that mealtime.
|
16 months
|
Costs to the hospital trust associated with implementing a volunteer mealtime assistance programme
Tidsram: 16 months
|
Staff costs in terms of time spent training and supporting volunteers will be recorded, as will any consumables required for the study.
The costs will be totalled to provide an overall cost estimate of implementing a volunteer mealtime assistance programme.
|
16 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Fiona Rossiter, MBChB, University Hospital Southampton NHS Foundation Trust
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- MED1203
- 14/LO/1363 (Annan identifierare: London-Chelsea Research Ethics Committee)
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