Multiple Chronic DiseasesNCT02715245
Multiple Chronic Diseases: the RITH Trial
A study testing Home-based rehabilitation in people with Multiple Chronic Diseases, run by Universidad de Almeria at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Chronic Diseases
- What is being tested?
- Home-based rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2013to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Torrecárdenas Hospital Complex (Almería) and Almería Health District
Almería, Almería
About this study
Official title: A Home-based Rehabilitation Program in 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.
Read the 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.
- Conditions
- Multiple Chronic Diseases
- Being tested
- Home-based rehabilitation
- Keywords
- home rehabilitation, Primary Health Care, Physiotherapy, chronic disease
- Medical subject headings
- Multiple Chronic Conditions, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based rehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Procedure: Home-based rehabilitation |
| Control Group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of daily living (ADLs)
The Barthel Index to measure functional, activities of daily living (ADLs) (Mahoney and Barthel, 1965).
Measured: The Barthel Index is assessing a change between initial assessment, at 2, 6 and 12 months
Secondary outcomes (1)
Risk of falls
The risk of falls (Jonson Down questionnaire)
Measured: Changes between initial assessment, at 2, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study start8 Jan 2013
- Primary completion30 Sep 2015
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Chronic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- Torrecárdenas Hospital, Almería Health District
- Responsible party
- Principal investigator, Remedios López Liria, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715245
- Sponsor's protocol ID
- CEIC-AL 39/2012
- Status last verified
- Oct 2017
- First submitted
- 18 Jan 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 28705187
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-based Rehabilitation Program in Multiple Chronic Diseases: the RITH Trial
- ClinicalTrials.gov ID
- NCT02715245
- Acronym / sponsor ID
- CEIC-AL 39/2012
- Conditions
- Multiple Chronic Diseases
- Keywords
- home rehabilitation, Primary Health Care, Physiotherapy, chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- Torrecárdenas Hospital, Almería Health District
- Study start
- 8 Jan 2013 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Home-based rehabilitationPatients 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. |
| Control Group | No intervention | –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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based rehabilitationProcedure/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. | Procedure or surgery | Experimental Group |
Primary outcome
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).
1 secondary outcome
Risk of falls
Time frame: Changes between initial assessment, at 2, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 28705187Vega-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based rehabilitation in people with Multiple Chronic Diseases, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities of daily living (ADLs) (time frame: The Barthel Index is assessing a change between initial assessment, at 2, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02715245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.