Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03129425
Status:
COMPLETED
Last Update Posted:
2020-09-23
First Post:
2017-04-11
Brief Title:
Quasi-experimental Study With a Control Group to Evaluate a Psychoeducational Intervention in Parkinsons Disease Patients and Carers
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
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 Parkinsons Disease Patients and Cares
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReNACE-PD01
Brief 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 Parkinsons 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 Parkinsons 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 Parkinsons 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 Parkinsons 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
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 Parkinsons 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 Parkinsons 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 Parkinsons 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 Parkinsons 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 230 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
Letters will be sent from the centers themselves to the homes of all the people diagnosed with Parkinsons 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 230 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None