Multiple Chronic Diseases: the RITH Trial

Not Applicable

Completed

• Conditions: Multiple Chronic Diseases
• Interventions: Procedure: Home-based rehabilitation

• Registration Number: NCT02715245
• Lead Sponsor: Universidad de Almeria

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.

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 Timeline

• Study Start: 2013-01-08
• Primary Completion: 2015-09-30
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Study Completion: 2016-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Home-based rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Torrecárdenas Hospital Complex (Almería) and Almería Health District; 🇪🇸 Almeria, Almería, Spain