Quasi-experimental Study With a Control Group to Evaluate a Psychoeducational Intervention in Parkinson's Disease Patients and Carers (ReNACE-PD01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03129425|
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Behavioral: ReNACE Psychoeducational Intervention Other: General Educational Program||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Intervention group
Sessions in groups
Behavioral: ReNACE Psychoeducational Intervention
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.
Other Name: Experimental group
Sham Comparator: Control group
Sessions in groups
Other: General Educational Program
5 sessions in groups of 15-20 people
Other Name: Control group
- 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)
- Change from Baseline Coping at 9 weeks and 24 weeks (6 months) [ Time Frame: Baseline, 9 weeks and 24 weeks ]The scale of Brief Cope for patients and family carers
- Change from Baseline Psychosocial adaptation to illness at 9 weeks and 24 weeks (6 months) [ Time Frame: Baseline, 9 weeks and 24 weeks ]The scale PAIS-SR for patients and family carers (PAIS-SR: the Psychosocial Adjustment to Illness Scale Self-report)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129425
|Contact: Mario Riverolfirstname.lastname@example.org|
|Servicio Navarro de Salud-Osasunbidea||Recruiting|
|Pamplona, Navarra, Spain|
|Contact: Mario Riverol +34948255400 email@example.com|
|Principal Investigator: Mario Riverol|
|Principal Investigator: M Carmen Portillo|
|Sub-Investigator: M Victoria Navarta-Sánchez|
|Sub-Investigator: M Eugenia Ursúa Sesma|
|Sub-Investigator: Leire Ambrosio|
|Sub-Investigator: M Jesús Álvarez|
|Sub-Investigator: Sara Díaz de Cerio|
|Sub-Investigator: Maite Medina|
|Sub-Investigator: Juana M Senosiain|
|Sub-Investigator: Raquel Martín-Lanas|
|Sub-Investigator: Arantza Gorraiz|
|Sub-Investigator: Neus Caparrós|
|Sub-Investigator: Sagrario Anaut|
|Sub-Investigator: Miriam Recio|
|Study Chair:||Francisco Javier Mata Rodríguez||Director Research Department (OTRI). University of Navarre.|