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Completed

NCT Number: NCT02715245

Multiple Chronic Diseases: the RITH Trial

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.

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Key information

Conditions

Multiple Chronic Diseases Chronic Disease Disease Attributes Multiple Chronic Conditions Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Torrecárdenas Hospital Complex (Almería) and Almería Health District

Almería, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-based rehabilitation

Procedure

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 outcomes

  1. 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).

Secondary outcomes

  1. Risk of falls

    Time frame: Changes between initial assessment, at 2, 6 and 12 months

    The risk of falls (Jonson Down questionnaire)

Other outcomes

  1. Cognitive state

    Time frame: Changes between initial assessment, at 2, 6 and 12 months

    The cognitive state with Pfeiffer Scale (Pfeiffer, 1975)

  2. 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)

  3. Hospital readmissions

    Time frame: Hospital readmissions assessment at 12 months

    number of hospital readmissions

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Collaborators

  • Almería Health District
  • Torrecárdenas Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 22, 2016
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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