Multiple Chronic Diseases: the RITH Trial

Sponsor

Universidad de Almeria (Other)

Overall Status

Completed

CT.gov ID

NCT02715245

Collaborator

Torrecárdenas Hospital (Other), Almería Health District (Other)

300

Enrollment

Location

Arms

44.7

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Chronic Diseases	Procedure: Home-based rehabilitation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

300 participants

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

Actual Study Start Date :

Jan 8, 2013

Actual Primary Completion Date :

Sep 30, 2015

Actual Study Completion Date :

Sep 30, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Activities of daily living (ADLs) [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 [Changes between initial assessment, at 2, 6 and 12 months]
The risk of falls (Jonson Down questionnaire)

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.