Parkinson DiseaseReNACE-PD01NCT03129425
Quasi-experimental Study With a Control Group to Evaluate a Psychoeducational Intervention in Parkinson's Disease Patients and Carers
A study testing ReNACE Psychoeducational Intervention and General Educational Program in people with Parkinson Disease, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the effects of a psychoeducational multidisciplinary intervention focusing on improving coping skills, the psychosocial adaptation to Parkinson's disease and the quality of life in patents and family carers in a Primary Care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- ReNACE Psychoeducational Intervention and General Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to 1 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with Parkinson's disease receiving care as outpatients in the designated centers in any stage of the disease (as determined by a researcher with the Hoehn \& Yahr scale), residing at that time in Navarra, fluent in the speaking and understanding of the Spanish language, and with preserved cognitive ability.
- Family members/carers will be over the age of 18, living or maintaining a close relationship with a patient and actively collaborating in the care of the patient, currently residing in Navarra and fluent in the speaking and understanding of the Spanish language
Who cannot join
- People with Parkinson's disease and family members who do not wish to participate.
- People with Parkinson's disease and family members who do not meet the inclusion criteria because of any event during the study time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quasi-experimental Study With a Control Group to Evaluate a Multidisciplinary Psychoeducational Intervention on Coping Skills, Psychosocial Adaptation and Quality of Life in Parkinson's Disease Patients and Cares
The aim of this study is to evaluate the effects of a psychoeducational multidisciplinary intervention focusing on improving coping skills, the psychosocial adaptation to Parkinson's disease and the quality of life in patents and family carers in a Primary Care setting.
On the basis of previous research, the hypothesis we propose is that through the development of coping skills which will contribute to promoting a positive psychosocial adaptation to Parkinson' disease, the quality of life of the people with Parkinson's disease and their family carers will be improved. At the same time, it is predicted that, by incorporating this psychoeducational intervention into clinical practice, the patients and family caregivers will perceive a greater sense of normality in their lives, which will also promote compliance with drug treatments and promote healthy lifestyles. In the long-term, such an approach could have positive effects on the overall health of patients and their family carers.
This quasi-experimental study with control group and mixed methods was designed to evaluate the ReNACE psychoeducational intervention (ReNACE is the spanish acronym for the Research Programme and means Recovery, Normalisation, Acceptance and Living with Chronic illness). Based on the relevant study power calculations, 100 people with Parkinson's disease and 100 family carers will be recruited. Participants will be assigned to two groups. The intervention group will receive the ReNACE psychoeducational intervention. The control group will be given a general educational program. The study will be carried out in community-based health centers. The results obtained from the two groups will be evaluated at three time points: at baseline, immediately after the intervention and at 6 months after the intervention. The results will be measured with the following instruments: the Quality of Life Scale PDQ-39 (The 39-item Parkinson's Disease Questionnaire) for patients and the Quality of Life Scale for caregivers SQLC (Scale of Quality of Life of Caregivers) for family carers, and for patients and family carers the Psychosocial Adjustment to Illness Scale Self-report (PAIS-SR) and the Brief Cope Inventory. To determine the acceptability of the intervention, focus groups will be organized with some patients and family carers who have received the ReNACE intervention and also with the healthcare professionals involved in its development.
Read the detailed description
Registry procedures
- Letters will be sent from the centers themselves to the homes of all the people diagnosed with Parkinson's disease who meet the inclusion criteria. The letters will contain information about the study and how to join the study, a stamped addressed envelope and the informed consent form. Those interested may sign up for the study by telephone, by sending a letter in a stamped addressed envelope (provided by the research team) or in person at the reception of the participating centers. Subsequently, a member of the research team will evaluate if the potential participants meet the inclusion criteria by means of a brief interview in the health center. Once it has been established that participants fulfill the inclusion criteria, they will be given a document with the dates of the sessions that they must attend.
- The healthcare professionals helping the participants in data collection will be blinded to intervention assignment. Two researchers will be in charge of data monitoring.
- Data will be compared with findings from papers.
- The sample size necessary to detect medium to large differences in the primary outcome of the project, quality of life, was calculated. The parameters used for the calculation of the sample size by group will be published in a paper.
- Analysis of quantitative data will be performed on an intention to treat basis and for that SPSS (Statistical Package for the Social Sciences) version 23.0 will be used. A descriptive analysis of the sociodemographic data will be made. For the quantitative variables, the means of central tendency and standard deviations will be calculated. Non-parametric tests (χ² tests) and parametric tests (paired student t tests) to compare patients with family members at each measurement points, unpaired student t tests to determine any significant differences between the two groups at baseline (Time 0) and the measurements at Time 1 and Time 2 will be used. Also, repeated measures of covariance (ANCOVA, analysis of covariance) will be used to compare differences between the two groups in the main variables.
- Conditions
- Parkinson Disease
- Being tested
- ReNACE Psychoeducational Intervention, General Educational Program
- Keywords
- Patient, Caregiver, Coping, Psychosocial adaptation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReNACE Psychoeducational InterventionBehavioural
Also called Experimental group
9 sessions in groups of 15-20 people at most so as to promote reflection and facilitate the interchange of opinions between participants about issues of interest from their day to day experience of coping with Parkinson's disease.
General Educational ProgramOther
Also called Control group
5 sessions in groups of 15-20 people
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Sessions in groups Receives: Behavioral: ReNACE Psychoeducational Intervention |
| Control group | Sham comparator | Sessions in groups Receives: Other: General Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Quality of life at 9 weeks and 24 weeks (6 months) in patients with Parkinson's disease
The quality of life is measured by the PDQ-39 (the 39-item Parkinson's Disease Questionnaire)
Measured: Baseline, 9 weeks and 24 weeks
Change from Baseline Quality of life at 9 weeks and 24 weeks (6 months) in family carers
The quality of life is measured by the SQLC (Scale of Quality of Life of Caregivers)
Measured: Baseline, 9 weeks and 24 weeks
Secondary outcomes (2)
Change from Baseline Coping at 9 weeks and 24 weeks (6 months)
The scale of Brief Cope for patients and family carers
Measured: Baseline, 9 weeks and 24 weeks
Change from Baseline Psychosocial adaptation to illness at 9 weeks and 24 weeks (6 months)
The scale PAIS-SR for patients and family carers (PAIS-SR: the Psychosocial Adjustment to Illness Scale Self-report)
Measured: Baseline, 9 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study startMar 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2018
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 Parkinson DiseaseStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco Javier Mata Rodríguez, Study chair, Director Research Department (OTRI). University of Navarre.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129425
- Sponsor's protocol ID
- ReNACE-PD01
- Acronym
- ReNACE-PD01
- Status last verified
- Sep 2020
- First submitted
- 11 Apr 2017
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data from scales will not be shared with other researchers.
Publications
Navarta-Sanchez MV, Ursua ME, Riverol Fernandez M, Ambrosio L, Medina M, Diaz de Cerio S, Alvarez MJ, Senosiain JM, Gorraiz A, Caparros N, Anaut S, Martin-Lanas R, Recio M, Portillo MC. Implementation of a multidisciplinary psychoeducational intervention for Parkinson's disease patients and carers in the community: study protocol. BMC Fam Pract. 2018 Apr 5;19(1):45. doi: 10.1186/s12875-018-0730-9.
PubMed 29621985
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quasi-experimental Study With a Control Group to Evaluate a Multidisciplinary Psychoeducational Intervention on Coping Skills, Psychosocial Adaptation and Quality of Life in Parkinson's Disease Patients and Cares
- ClinicalTrials.gov ID
- NCT03129425
- Acronym / sponsor ID
- ReNACE-PD01 / ReNACE-PD01
- Conditions
- Parkinson Disease
- Keywords
- Patient, Caregiver, Coping, Psychosocial adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 26 Apr 2017 (actual)
- 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.
The aim of this study is to evaluate the effects of a psychoeducational multidisciplinary intervention focusing on improving coping skills, the psychosocial adaptation to Parkinson's disease and the quality of life in patents and family carers in a Primary Care setting.
On the basis of previous research, the hypothesis we propose is that through the development of coping skills which will contribute to promoting a positive psychosocial adaptation to Parkinson' disease, the quality of life of the people with Parkinson's disease and their family carers will be improved. At the same time, it is predicted that, by incorporating this psychoeducational intervention into clinical practice, the patients and family caregivers will perceive a greater sense of normality in their lives, which will also promote compliance with drug treatments and promote healthy lifestyles. In the long-term, such an approach could have positive effects on the overall health of patients and their family carers.
This quasi-experimental study with control group and mixed methods was designed to evaluate the ReNACE psychoeducational intervention (ReNACE is the spanish acronym for the Research Programme and means Recovery, Normalisation, Acceptance and Living with Chronic illness). Based on the relevant study power calculations, 100 people with Parkinson's disease and 100 family carers will be recruited. Participants will be assigned to two groups. The intervention group will receive the ReNACE psychoeducational intervention. The control group will be given a general educational program. The study will be carried out in community-based health centers. The results obtained from the two groups will be evaluated at three time points: at baseline, immediately after the intervention and at 6 months after the intervention. The results will be measured with the following instruments: the Quality of Life Scale PDQ-39 (The 39-item Parkinson's Disease Questionnaire) for patients and the Quality of Life Scale for caregivers SQLC (Scale of Quality of Life of Caregivers) for family carers, and for patients and family carers the Psychosocial Adjustment to Illness Scale Self-report (PAIS-SR) and the Brief Cope Inventory. To determine the acceptability of the intervention, focus groups will be organized with some patients and family carers who have received the ReNACE intervention and also with the healthcare professionals involved in its development.
Detailed description
Registry procedures
- Letters will be sent from the centers themselves to the homes of all the people diagnosed with Parkinson's disease who meet the inclusion criteria. The letters will contain information about the study and how to join the study, a stamped addressed envelope and the informed consent form. Those interested may sign up for the study by telephone, by sending a letter in a stamped addressed envelope (provided by the research team) or in person at the reception of the participating centers. Subsequently, a member of the research team will evaluate if the potential participants meet the inclusion criteria by means of a brief interview in the health center. Once it has been established that participants fulfill the inclusion criteria, they will be given a document with the dates of the sessions that they must attend.
- The healthcare professionals helping the participants in data collection will be blinded to intervention assignment. Two researchers will be in charge of data monitoring.
- Data will be compared with findings from papers.
- The sample size necessary to detect medium to large differences in the primary outcome of the project, quality of life, was calculated. The parameters used for the calculation of the sample size by group will be published in a paper.
- Analysis of quantitative data will be performed on an intention to treat basis and for that SPSS (Statistical Package for the Social Sciences) version 23.0 will be used. A descriptive analysis of the sociodemographic data will be made. For the quantitative variables, the means of central tendency and standard deviations will be calculated. Non-parametric tests (χ² tests) and parametric tests (paired student t tests) to compare patients with family members at each measurement points, unpaired student t tests to determine any significant differences between the two groups at baseline (Time 0) and the measurements at Time 1 and Time 2 will be used. Also, repeated measures of covariance (ANCOVA, analysis of covariance) will be used to compare differences between the two groups in the main variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: ReNACE Psychoeducational InterventionSessions in groups |
| Control group | Sham comparator | Other: General Educational ProgramSessions in groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People with Parkinson's disease receiving care as outpatients in the designated centers in any stage of the disease (as determined by a researcher with the Hoehn \& Yahr scale), residing at that time in Navarra, fluent in the speaking and understanding of the Spanish language, and with preserved cognitive ability.
- Family members/carers will be over the age of 18, living or maintaining a close relationship with a patient and actively collaborating in the care of the patient, currently residing in Navarra and fluent in the speaking and understanding of the Spanish language
Key exclusion criteria (2 listed)
- People with Parkinson's disease and family members who do not wish to participate.
- People with Parkinson's disease and family members who do not meet the inclusion criteria because of any event during the study time.
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 |
|---|---|---|
| ReNACE Psychoeducational InterventionAlso: Experimental group9 sessions in groups of 15-20 people at most so as to promote reflection and facilitate the interchange of opinions between participants about issues of interest from their day to day experience of coping with Parkinson's disease. | Behavioural | Intervention group |
| General Educational ProgramAlso: Control group5 sessions in groups of 15-20 people | Other | Control group |
Primary outcome
Change from Baseline Quality of life at 9 weeks and 24 weeks (6 months) in patients with Parkinson's disease
Time frame: Baseline, 9 weeks and 24 weeks
The quality of life is measured by the PDQ-39 (the 39-item Parkinson's Disease Questionnaire)
Change from Baseline Quality of life at 9 weeks and 24 weeks (6 months) in family carers
Time frame: Baseline, 9 weeks and 24 weeks
The quality of life is measured by the SQLC (Scale of Quality of Life of Caregivers)
2 secondary outcomes
Change from Baseline Coping at 9 weeks and 24 weeks (6 months)
Time frame: Baseline, 9 weeks and 24 weeks
Change from Baseline Psychosocial adaptation to illness at 9 weeks and 24 weeks (6 months)
Time frame: Baseline, 9 weeks and 24 weeks
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 23 Sep 2020.
- Derived from this study: PubMed 29621985Navarta-Sanchez MV, Ursua ME, Riverol Fernandez M, Ambrosio L, Medina M, Diaz de Cerio S, Alvarez MJ, Senosiain JM, Gorraiz A, Caparros N, Anaut S, Martin-Lanas R, Recio M, Portillo MC. Implementation of a multidisciplinary psychoeducational intervention for Parkinson's disease patients and carers in the community: study protocol. BMC Fam Pract. 2018 Apr 5;19(1):45. doi: 10.1186/s12875-018-0730-9.
- Individual participant dataSharing planned: No. Participant data from scales will not be shared with other researchers.
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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.
Francisco Javier Mata Rodríguez study chair
Director Research Department (OTRI). University of Navarre.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReNACE Psychoeducational Intervention and General Educational Program in people with Parkinson Disease, run by Clinica Universidad de Navarra, Universidad de Navarra 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 2 inclusion and 2 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 23 Sep 2020. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline Quality of life at 9 weeks and 24 weeks (6 months) in patients with Parkinson's disease (time frame: Baseline, 9 weeks and 24 weeks). The study lists 2 primary outcomes in all. 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 NCT03129425, 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 23 Sep 2020.