Multiple Chronic Diseases: the RITH Trial

Overview

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.

Full Title of Study: “A Home-based Rehabilitation Program in Multiple Chronic Diseases: the RITH Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 30, 2015

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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

Clinical Trial Outcome Measures

Primary 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad de Almeria
  • Collaborator
    • Torrecárdenas Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Remedios López Liria, PhD. – Universidad de Almeria

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