Multiple Chronic Diseases: the RITH Trial

October 26, 2017 updated by: Remedios López Liria, Universidad de Almeria

A Home-based Rehabilitation Program in Multiple Chronic Diseases: the RITH Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Experimental group consisted of patients with multiple chronic diseases referred to services in the province of Almería that comply the inclusion criteria and their caregivers. Outcome measures: sex, age, location, primary caregiver, disabling process, number and type of categories including by multiple pathologies, personal history, assessment (physical and functional), Barthel Index, Lawton and Brody index, risk of falls, Scale Pfeiffer, social support, caregiver burden, hospital readmissions and length, technical aids. Quality of Life (SF-12) and degree of user satisfaction. Regarding the intervention: date of application, date of assessment, objectives, treatment / intervention techniques, number of sessions, staff time spent.

Control Group: Patients with multiple diseases and their caregivers, belonging to health centers or areas where there is no figure nurse case manager or MRPTT. Registration information will consist of the same assessments, questionnaires and scales that are comparable to the experimental and control groups for analysis.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Almería
      • Almeria, Almería, Spain
        • Torrecárdenas Hospital Complex (Almería) and Almería Health District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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
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.
No Intervention: Control Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities of daily living (ADLs)
Time Frame: The Barthel Index is assessing a change between initial assessment, at 2, 6 and 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of falls
Time Frame: Changes between initial assessment, at 2, 6 and 12 months
The risk of falls (Jonson Down questionnaire)
Changes between initial assessment, at 2, 6 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive state
Time Frame: Changes between initial assessment, at 2, 6 and 12 months
The cognitive state with Pfeiffer Scale (Pfeiffer, 1975)
Changes between initial assessment, at 2, 6 and 12 months
The Social Support State
Time Frame: Changes between initial assessment, at 2, 6 and 12 months
The Social Support State ( assessed with the Gijon abbreviated questionnaire)
Changes between initial assessment, at 2, 6 and 12 months
Hospital readmissions
Time Frame: Hospital readmissions assessment at 12 months
number of hospital readmissions
Hospital readmissions assessment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Collaborators

Torrecárdenas Hospital
Almería Health District

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2013

Primary Completion (Actual)

September 30, 2015

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC-AL 39/2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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