Clinical trial NCT02715245: Multiple Chronic Diseases: the RITH Trial
Official title: A Home-based Rehabilitation Program in Multiple Chronic Diseases: the RITH Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chronic Diseases
Keywords: home rehabilitation
Primary Health Care
Physiotherapy
chronic disease
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Torrecárdenas Hospital
name: Almería Health District
First posted: 2016-03-22
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Activities of daily living (ADLs)
timeFrame: The Barthel Index is assessing a change between initial assessment, at 2, 6 and 12 months
Secondary outcomes:
measure: Risk of falls
timeFrame: Changes between initial assessment, at 2, 6 and 12 months
Other outcomes:
measure: Cognitive state
timeFrame: Changes between initial assessment, at 2, 6 and 12 months
measure: The Social Support State
timeFrame: Changes between initial assessment, at 2, 6 and 12 months
measure: Hospital readmissions
timeFrame: Hospital readmissions assessment at 12 months
Locations:
city: Almeria
country: Spain
facility: Torrecárdenas Hospital Complex (Almería) and Almería Health District
state: Almería
Study officials:
References:
citation: Vega-Ramirez FA, Lopez-Liria R, Granados-Gamez G, Aguilar-Parra JM, Padilla-Gongora D. Analysis of home-based rehabilitation in patients with motor impairment in primary care: a prospective observational study. BMC Geriatr. 2017 Jul 14;17(1):145. doi: 10.1186/s12877-017-0526-0.