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

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

Interventions

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

General Educational Program

5 sessions in groups of 15-20 people

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• Francisco Javier Mata Rodríguez · Director Research Department (OTRI). University of Navarre.

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2017-12-01

Completion

2018-12-01

Countries

• Spain

Study Locations