Quasi-experimental Study With a Control Group to Evaluate a Psychoeducational Intervention in Parkinson's Disease Patients and Carers

NCT03129425 | Completed

• 1 other identifier: ReNACE-PD01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Parkinson Disease

Keywords

Patient; Caregiver; Coping; Psychosocial adaptation

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Baseline, 9 weeks and 24 weeks

Secondary Outcomes (2)

• Change from Baseline Coping at 9 weeks and 24 weeks (6 months)

  Baseline, 9 weeks and 24 weeks

• Change from Baseline Psychosocial adaptation to illness at 9 weeks and 24 weeks (6 months)

  Baseline, 9 weeks and 24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Sessions in groups

Behavioral: ReNACE Psychoeducational Intervention

Control group

SHAM COMPARATOR

Sessions in groups

Other: General Educational Program

Interventions

ReNACE Psychoeducational Intervention BEHAVIORAL

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.

Also known as: Experimental group

Intervention group

General Educational Program OTHER

5 sessions in groups of 15-20 people

Also known as: Control group

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• People with Parkinson's disease and family members who do not wish to participate.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Servicio Navarro de Salud-Osasunbidea

Pamplona, Navarre, Spain

Location

Related Publications (1)

• 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.

  PMID: 29621985 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Francisco Javier Mata Rodríguez

  Director Research Department (OTRI). University of Navarre.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 26, 2017
• Study Start: March 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)