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Ambulatory Geriatric Evaluation - Frailty Intervention Trial (AGE-FIT)

29 mars 2014 mis à jour par: Anne Ekdahl, Linkoeping University

Effectiveness of a Comprehensive CGA on Frailty in Community-dwelling Elderly People - A Randomised, Controlled Trial

The main purpose of this randomised controlled trial is to study if a Comprehensive Geriatric Assessment (CGA) and follow up for community-dwelling elderly people can improve outcomes such as health and health-related quality of life among both patients and relatives, feeling of safety among both patients and relatives and reduce costs, compared with usual care.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Frail older adults are at increased risk of vulnerability and serious health problems. This leads to increased suffering and higher healthcare utilization. There are major gaps in the knowledge needed to create the most favourable care model for preventing frailty and increasing health-related of life. The purpose of this randomised controlled trial is to study if a Comprehensive Geriatric Assessment and follow up in community-dwelling elderly people can prevent frailty, hospitalisation and adverse effects of frailty, improve health and health-related quality of life, and reduce costs, compared with usual care. In a randomized, controlled trial with 24 months of follow-up, a total of 430 older adults with multimorbidity will be randomized into two groups. The intervention group will receive Comprehensive Geriatric Assessment and follow up and the same standard health care services as the control group. The Comprehensive Geriatric Assessment and follow up will be provides through an outpatient facility that tailors care from a holistic perspective and, based on each patient's individual needs in line with the policy program that Sweden's pensioners' organizations have presented in 2010 together with the Swedish Association of Geriatric Medicine. The team includes, among other things. a. geriatricians, nurses, physiotherapists, assistance officer, dietician, pharmacist and co-operation with the dental hygienist.

The primary outcome is development of frailty and hospitalization. Secondary outcomes are adverse effects of frailty, health and health-related quality of life and costs. There is a knowledge gap of how health care can identify persons with frailty and risks for frailty and how to meet their specific care needs. The study aims to fill a clinically important knowledge gap that can guide further development of future care for older people with multi-morbidity and frailty. CGA is readily transferable to clinical practice.

Type d'étude

Interventionnel

Inscription (Réel)

383

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Suède
      • Norrkoeping, Suède, 60182
        • Department of Geriatric Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

75 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Elderly 75 years and above
  • Have been hospitalized three or more times in the last 12 months
  • Have three or more diagnoses in their medical records according to the International Classification of Diseases (ICD-10)
  • Live in their own homes (not nursing home) in the municipality of Norrkoeping
  • Accept to participate in the study.

Exclusion criteria:

- Fulfilling the inclusion criteria but living in a special accommodation for the elderly

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: The intervention group
The intervention group will receive Comprehensive Geriatric Assessment and follow up as a complement to the same standard health care services as the control group. The Comprehensive Geriatric Assessment and follow up will be provides through an outpatient facility that tailors care from a holistic perspective and, based on each patient's individual needs in line with the policy program that Sweden's pensioners' organizations have presented in 2010 together with the Swedish Association of Geriatric Medicine. The team includes, among other things. a. geriatricians, nurses, physiotherapists, assistance officer, dietician, pharmacist and co-operation with the dental hygienist.
Procédure: The intervention group
Medical assessment (co-morbid condition, physical and neurological examination, medication review, nutrition, and blood-tests to identify anaemia, diabetes, metabolism and liver- and kidney function); assessment of functioning (ADL/IADL, fall risk), psychological assessment (cognitive decline and depression) and assessment of social and environmental conditions. The care plan is based on the CGA and will be individualised and carried out in discussion with the patient and his/her caregivers. The care will be carried out by an inter-professional Geriatric Team with employees from both the county council and the municipality. The team consists of a core team (including geriatrician and nurse) and a support team (including a social worker, occupational therapist, dietician, pharmacist, physiotherapist, and dental hygienist). The care will involve treatment for unstable medical conditions and support of patients and their caregivers. The team will have regular team conferences.
Autres noms:
  • Geriatric care team
Comparateur placebo: Control group
The control group will receive care in the same way as usual meaning access to primary care, hospital in- and outpatient care and care received by the municipality. The only difference between the two groups are that the control group will not have access to the geriatric care team.
Procédure: control group
No intervention

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Hospitalisation
Délai: 24 months
Number of hospitalisations and in-care stays during the trial
24 months
Frailty
Délai: 24 months
Unintentional weight loss ≥5% of the previous year. Exhaustion is assessed by two questions from the Centre for Epidemiologic Studies-Depression Scale. Low physical activity includes assessment of habitual physical activity level by using the Swedish version of the International Physical Activity Questionnaire short version (IPAQ-S).Slow walking speed is determined from the better of two attempts at usual "comfortable" walking speed over 4 m with or without a walking aid. Weakness (muscle strength) is assessed by maximal grip strength.
24 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cognition
Délai: 0 and 24 months
Cognition is assessed by the Mini-Mental State Examination
0 and 24 months
Symptoms
Délai: 0 and 24 months
Symptoms experienced during the previous week (frequency, intensity, and distress) are assessed by the "The Memorial Symptom Assessment Scale" (MSAS), which measures 32 different symptoms.
0 and 24 months
Depression
Délai: 0 and 24 months
Depression is assessed using the Geriatric Depression Scale (GDS-15
0 and 24 months
Health related quality of life
Délai: 0 and 24 months
Health related quality of life (HRQL) is assessed by using the Nottingham Health Profile, first part (NHP) and the generic "EuroQol" questionnaire (EQ-5D)
0 and 24 months
Nutrition
Délai: 0 and 24 months
The Mini Nutritional Assessment form (MNA), is used to assess nutritional status. The MNA includes 18 items.
0 and 24 months
Activities of Daily Living
Délai: 0 and 24 months
Barthels index
0 and 24 months
Falls
Délai: 0 and 24 months
the patient is asked about falls in the last 6 months
0 and 24 months
Costs
Délai: 24 months
1) Contact and extent of contact with the municipality measured by working hours 2) Number of: visits to day-care centres, in-hospital stays (type of clinic and extent of these), visits to primary care facilities, geriatric ambulatories or other specialist ambulatories 3) Admissions to nursing care facilities
24 months
Feeling of security of the patient
Délai: 0, 12 and 24 months
Questionnaire
0, 12 and 24 months
Feeling of security of the relatives
Délai: 0, 12 and 24 months
Questionnaire
0, 12 and 24 months
Quality of life of relatives
Délai: 0, 12 and 24 months
Questionnaire
0, 12 and 24 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Linkoeping University

Collaborateurs

Swedish Association of Local Authorities and Regions

Les enquêteurs

  • Chercheur principal: Anne W Ekdahl, Physisian, Linkopeing University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2011

Achèvement primaire (Réel)

1 décembre 2013

Achèvement de l'étude (Réel)

1 janvier 2014

Dates d'inscription aux études

Première soumission

19 septembre 2011

Première soumission répondant aux critères de contrôle qualité

4 octobre 2011

Première publication (Estimation)

5 octobre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

1 avril 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 mars 2014

Dernière vérification

1 mars 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2011/41-31

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