Condition category
Not Applicable
Date applied
17/03/2008
Date assigned
04/04/2008
Last edited
07/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.isciii.es

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

  1. 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.

Additional files

Editorial Notes