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Multiple Chronic Diseases: the RITH Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02715245
First Posted: March 22, 2016
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Torrecárdenas Hospital
Almería Health District
Information provided by (Responsible Party):
Remedios López Liria, Universidad de Almeria
  Purpose
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.

Condition Intervention
Multiple Chronic Diseases Procedure: Home-based rehabilitation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: A Home-based Rehabilitation Program in Multiple Chronic Diseases: the RITH Trial

Resource links provided by NLM:


Further study details as provided by Remedios López Liria, Universidad de Almeria:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • Risk of falls [ Time Frame: Changes between initial assessment, at 2, 6 and 12 months ]
    The risk of falls (Jonson Down questionnaire)


Other Outcome Measures:
  • Cognitive state [ Time Frame: Changes between initial assessment, at 2, 6 and 12 months ]
    The cognitive state with Pfeiffer Scale (Pfeiffer, 1975)

  • 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)

  • Hospital readmissions [ Time Frame: Hospital readmissions assessment at 12 months ]
    number of hospital readmissions


Enrollment: 300
Actual Study Start Date: January 8, 2013
Study Completion Date: September 30, 2016
Primary Completion Date: September 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715245


Locations
Spain
Torrecárdenas Hospital Complex (Almería) and Almería Health District
Almeria, Almería, Spain
Sponsors and Collaborators
Universidad de Almeria
Torrecárdenas Hospital
Almería Health District
  More Information

Responsible Party: Remedios López Liria, PhD., Universidad de Almeria
ClinicalTrials.gov Identifier: NCT02715245     History of Changes
Other Study ID Numbers: CEIC-AL 39/2012
First Submitted: January 18, 2016
First Posted: March 22, 2016
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Keywords provided by Remedios López Liria, Universidad de Almeria:
home rehabilitation
Primary Health Care
Physiotherapy
chronic disease

Additional relevant MeSH terms:
Chronic Disease
Multiple Chronic Conditions
Disease Attributes
Pathologic Processes