Multiple Chronic Diseases: the RITH Trial
|ClinicalTrials.gov Identifier: NCT02715245|
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Chronic Diseases||Procedure: Home-based rehabilitation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|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 :||January 8, 2013|
|Actual Primary Completion Date :||September 30, 2015|
|Actual Study Completion Date :||September 30, 2016|
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
- Activities of daily living (ADLs) [ Time Frame: 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).
- Risk of falls [ Time Frame: Changes between initial assessment, at 2, 6 and 12 months ]The risk of falls (Jonson Down questionnaire)
- Cognitive state [ Time Frame: Changes between initial assessment, at 2, 6 and 12 months ]The cognitive state with Pfeiffer Scale (Pfeiffer, 1975)
- The Social Support State [ Time Frame: Changes between initial assessment, at 2, 6 and 12 months ]The Social Support State ( assessed with the Gijon abbreviated questionnaire)
- Hospital readmissions [ Time Frame: Hospital readmissions assessment at 12 months ]number of hospital readmissions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715245
|Torrecárdenas Hospital Complex (Almería) and Almería Health District|
|Almeria, Almería, Spain|