NCT02715245

Brief Summary

In this research, investigators pretent to evaluate the effectiveness of clinical, functional, psychological and social impact of an intervention model based on shared care between the Mobile Rehabilitation and Physical therapy team (MRPTT) and nurse case managers of Primary Care in a sample of patients with multiple chronic diseases (comorbidities) and their caregivers. A non-randomised controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

January 18, 2016

Last Update Submit

October 26, 2017

Conditions

Multiple Chronic Diseases

Keywords

home rehabilitationPrimary Health CarePhysiotherapychronic disease

Outcome Measures

Primary Outcomes (1)

  • Activities of daily living (ADLs)

    The Barthel Index to measure functional, activities of daily living (ADLs) (Mahoney and Barthel, 1965).

    The Barthel Index is assessing a change between initial assessment, at 2, 6 and 12 months

Secondary Outcomes (1)

  • Risk of falls

    Changes between initial assessment, at 2, 6 and 12 months

Other Outcomes (3)

  • Cognitive state

    Changes between initial assessment, at 2, 6 and 12 months

  • The Social Support State

    Changes between initial assessment, at 2, 6 and 12 months

  • Hospital readmissions

    Hospital readmissions assessment at 12 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Patients with multiple chronic disease referred to Mobile Rehabilitation and Physical therapy team (MRPTT) and Nurse-led case Management in the province of Almeria that comply the inclusion criteria; as well as their caregivers.

Procedure: Home-based rehabilitation

Control Group

NO INTERVENTION

Patients with multiple chronic disease and their caregivers belonging to health centers or areas where there is no figure MRPTT or Nurse-led case Management to reach this population

Interventions

Home-based rehabilitationPROCEDURE

Procedure/Surgery: Home-based rehabilitation In the patient's home, the primarily applied treatment has been physical therapy, seeking to achieve the highest possible functionality and gait training. In more than 25% of cases, health education is conducted for families and caregivers. Thus, consistent with the patient's condition and their tolerance to activity and to exercise their self-care independently, rehabilitation interventions are activated that prevent sequelae derived from functional limitations.

Experimental Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with multiple chronic diseases that are referred to the nurse case managers and home rehabilitation.
  • Detected in Hospital or Primary Care.
  • To provide informed consent to participate in research.

You may not qualify if:

  • clinical situation of agony;
  • No acceptance of treatment by the patient or family
  • Refuse to participate in the study
  • Lack of cooperation of the patient or caregiver.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Torrecárdenas Hospital Complex (Almería) and Almería Health District

Almería, Almería, Spain

Location

Related Publications (1)

  • Vega-Ramirez FA, Lopez-Liria R, Granados-Gamez G, Aguilar-Parra JM, Padilla-Gongora D. Analysis of home-based rehabilitation in patients with motor impairment in primary care: a prospective observational study. BMC Geriatr. 2017 Jul 14;17(1):145. doi: 10.1186/s12877-017-0526-0.

    PMID: 28705187DERIVED

MeSH Terms

Conditions

Multiple Chronic ConditionsChronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

January 18, 2016

First Posted

March 22, 2016

Study Start

January 8, 2013

Primary Completion

September 30, 2015

Study Completion

September 30, 2016

Last Updated

October 27, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

According to current legislation ( RD 1090/2015 , Decree 439/210 ) and Law 14/2007 on Biomedical and Health Sciences Research, which regulates the process of clinical trials / observational studies, is the responsibility of the investigator to report regularly to the Committee on Ethics in Research Almeria ( Almería CEI ) the progress of the clinical trial / observational study.

Locations

ES(1)