Contact information
Type
Scientific
Primary contact
Dr Jose Miguel Morales-Asencio
ORCID ID
Contact details
Cuesta del Observatorio s/n
Granada
18080
Spain
+34 670948689
josem.morales.easp@juntadeandalucia.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI031161I
Study information
Scientific title
Acronym
ENMAD
Study hypothesis
A nurse-led case management home care system improves:
1. Functional status of the patients
2. Use of social and health resources
3. Satisfaction (both patients and caregivers)
Ethics approval
Ethics Committees of the Andalusian School of Public Health (Spain). Date of approval: 21/02/2003
Study design
Quasi-experimental, prospective, multi-centre study, with a concurrent control group
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Condition
Long term home care.
Intervention
Patients and main caregivers were allocated to either the intervention or control group, depending on whether or not they had access to home care services delivered in line with the new model by their Healthcare Centre.
The period for enrolment of subjects and inclusion in the sample started at the various healthcare centres six months after case management nurses initiated the programme. This gave nursing staff sufficient time to adapt to their new functions and roles.
Main activities:
1. Action Plan and Follow-up: Protocol-dependent home visits and care delivery plan
2. Data management: Clinical record, pilot sheet, registry of home care and information system
3. Co-ordination with other members of the Primary Care Basic Teams (PCBTs)
4. Referral criteria
5. Healthcare education guidelines, support to patients and caregivers
6. Review of target population census
7. Home care visit with integral assessment and detection of needs upon request from team members
8. Establishing co-ordination mechanisms with PCBTs
9. Designing and implementing co-ordination mechanisms with other institutions and professionals
10. Arranging technical assistance at home
11. Enrolment of new cases
12. Specific activities with caregivers
13. Taking part in commissions for ongoing assistance
14. Tele-care
Duration of interventions: 2.5 years (30 months)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Patient's functional capacity (Barthel and Lawton-Brody scales) at 0, 2, 6 and 12 months
2. Satisfaction (SATISFAD, specific questionnaire validated for assessment of satisfaction with home care services) at 2, 6 and 12 months
3. Hospital admissions
4. Accident & Emergency (A&E) visits
5. Home visits by nurses
6. Social worker interventions
7. Physiotherapy sessions
8. Caregiver visits to healthcare centre
9. Patient visits to healthcare centre
Secondary outcome measures
1. Caregiver burden (Zarit test) at 0, 2, 6 and 12 months
2. Family role/function (APGAR family test) at 0, 2, 6 and 12 months
3. Cognitive function (Pfeiffer test) at 0, 2, 6 and 12 months
4. Quality of life (Euro-QoL 5D) at 0, 2 and 6 months
5. Institutionalisation
6. Mortality
7. Management of therapeutic regimen
Overall trial start date
01/11/2003
Overall trial end date
30/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients and caregivers initiating the Home Care (HC) programme launched by the Andalusian Healthcare Service and targeting some of the following population sub-groups:
Sub-group 1: Terminally ill patients with advanced stage, progressive, incurable, multi-symptomatic disease with no reasonable chance of responding to specific treatment, with estimated survival not exceeding six months
Sub-group 2: Dependent patients who require assistance for their daily activities (Activities of Daily Living [ADL]) and are immobilised at home, namely subjects not included in Sub-group 1 who, for whatever cause, are forced to spend most of their time in bed and/or require help to move, which prevents them from leaving home, except for rare exceptions
Sub-group 3: Patients not included in Sub-groups 1 and 2, recently discharged from hospital, requiring home care during a short period of time, most likely for under two months
Sub-group 4: Main caregivers for any of the patients described in the previous sub-groups
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
286
Participant exclusion criteria
1. Institutionalisation or change of residence to an area not covered by the study, thus preventing the minimum follow-up required
2. Hospitalisation for longer than seven days, except for terminally ill patients who were readmitted for disease stabilisation and symptom control
Note: With these criteria in mind, the population potentially requiring home care services in the healthcare districts under the scope of the study was estimated at 1,032,333. Malaga with 50.93% of the total potential population was in a position to contribute the largest number of subjects to the study, followed by the Costa del Sol district with 20.46%, Almeria with 20.60% and lastly Granada with 8.55%.
Recruitment start date
01/11/2003
Recruitment end date
30/12/2006
Locations
Countries of recruitment
Spain
Trial participating centre
Cuesta del Observatorio s/n
Granada
18080
Spain
Sponsor information
Organisation
Ministry of Health (Spain)
Sponsor details
c/ Sinesio Delgado
nº 6 (Pabellón Nº 4)
Madrid
28029
Spain
oficina.informacion@isciii.es
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Spanish Health Research Fund of the National Health Ministry (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/pubmed/18811927
Publication citations
-
Results
Morales-Asencio JM, Gonzalo-Jiménez E, Martin-Santos FJ, Morilla-Herrera JC, Celdráan-Mañas M, Carrasco AM, García-Arrabal JJ, Toral-López I, Effectiveness of a nurse-led case management home care model in Primary Health Care. A quasi-experimental, controlled, multi-centre study., BMC Health Serv Res, 2008, 8, 193, doi: 10.1186/1472-6963-8-193.