Multiple Chronic Diseases: the RITH Trial

Multiple Chronic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715245
• Other study ID #: CEIC-AL 39/2012
• Status: Completed
• Phase: N/A
• First received: January 18, 2016
• Last updated: October 26, 2017
• Start date: January 8, 2013
• Est. completion date: September 30, 2016

Study information

• Verified date: October 2017
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Multiple Chronic Conditions
• Multiple Chronic Diseases

Intervention

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.

Locations

Country	Name	City	State
Spain	Torrecárdenas Hospital Complex (Almería) and Almería Health District	Almeria	Almería

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Almeria	Almería Health District, Torrecárdenas Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive state	The cognitive state with Pfeiffer Scale (Pfeiffer, 1975)	Changes between initial assessment, at 2, 6 and 12 months
Other	The Social Support State	The Social Support State ( assessed with the Gijon abbreviated questionnaire)	Changes between initial assessment, at 2, 6 and 12 months
Other	Hospital readmissions	number of hospital readmissions	Hospital readmissions assessment at 12 months
Primary	Activities of daily living (ADLs)	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	Risk of falls	The risk of falls (Jonson Down questionnaire)	Changes between initial assessment, at 2, 6 and 12 months