Multiple Chronic Diseases: the RITH Trial
Primary Purpose
Multiple Chronic Diseases
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Home-based rehabilitation
Sponsored by
About this trial
This is an interventional health services research trial for Multiple Chronic Diseases focused on measuring home rehabilitation, Primary Health Care, Physiotherapy, chronic disease
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.
Sites / Locations
- Torrecárdenas Hospital Complex (Almería) and Almería Health District
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Activities of daily living (ADLs)
The Barthel Index to measure functional, activities of daily living (ADLs) (Mahoney and Barthel, 1965).
Secondary Outcome Measures
Risk of falls
The risk of falls (Jonson Down questionnaire)
Full Information
NCT ID
NCT02715245
First Posted
January 18, 2016
Last Updated
October 26, 2017
Sponsor
Universidad de Almeria
Collaborators
Torrecárdenas Hospital, Almería Health District
1. Study Identification
Unique Protocol Identification Number
NCT02715245
Brief Title
Multiple Chronic Diseases: the RITH Trial
Official Title
A Home-based Rehabilitation Program in Multiple Chronic Diseases: the RITH Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 8, 2013 (Actual)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
September 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria
Collaborators
Torrecárdenas Hospital, Almería Health District
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chronic Diseases
Keywords
home rehabilitation, Primary Health Care, Physiotherapy, chronic disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Home-based rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Activities of daily living (ADLs)
Description
The Barthel Index to measure functional, activities of daily living (ADLs) (Mahoney and Barthel, 1965).
Time Frame
The Barthel Index is assessing a change between initial assessment, at 2, 6 and 12 months
Secondary Outcome Measure Information:
Title
Risk of falls
Description
The risk of falls (Jonson Down questionnaire)
Time Frame
Changes between initial assessment, at 2, 6 and 12 months
Other Pre-specified Outcome Measures:
Title
Cognitive state
Description
The cognitive state with Pfeiffer Scale (Pfeiffer, 1975)
Time Frame
Changes between initial assessment, at 2, 6 and 12 months
Title
The Social Support State
Description
The Social Support State ( assessed with the Gijon abbreviated questionnaire)
Time Frame
Changes between initial assessment, at 2, 6 and 12 months
Title
Hospital readmissions
Description
number of hospital readmissions
Time Frame
Hospital readmissions assessment at 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Torrecárdenas Hospital Complex (Almería) and Almería Health District
City
Almeria
State/Province
Almería
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
According to current legislation ( RD 1090/2015 , Decree 439/210 ) and Law 14/2007 on Biomedical and Health Sciences Research, which regulates the process of clinical trials / observational studies, is the responsibility of the investigator to report regularly to the Committee on Ethics in Research Almeria ( Almería CEI ) the progress of the clinical trial / observational study.
Citations:
PubMed Identifier
28705187
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.
Results Reference
derived
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Multiple Chronic Diseases: the RITH Trial
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