Effectiveness of a Psychoeducational Intervention on Myositis Patients' Quality of Life and Well-Being

NCT06300983 | Completed

• 1 other identifier: PR(AG)398/2022
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose. Myositis is a rare disease associated with impaired health-related quality of life. A study evaluating the effectiveness of an intervention to improve the quality of life and well-being of myositis patients is presented. Materials and Methods. All myositis patients in a health district are contacted. Eligible patients are randomly assigned to the experimental or control group. A psychoeducational intervention of 5 100-min sessions focusing on the disease as related to daily life is conducted only in experimental patients. Several reliable tools to measure quality of life and well-being are administered twice, before and after the intervention, to both groups.

Conditions

Quality of Life; Myositis

Keywords

Clinical trial; Inflammatory myopathy; Myositis; Psychoeducational intervention; Health related quality of life

Outcome Measures

Primary Outcomes (1)

• Health related quality of life

  WHOQOL-The WHOQOL-BREF consists of 26 items, with 24 items covering four domains: physical health, psychological health, social relationships, and environment. Additionally, 2 global questions inquire about overall quality of life and satisfaction with health. Participants rated each item on a 5-point scale, in which higher scores indicate better quality of life. The assessment was based on the experiences of the past 2 weeks. Results from the 4 domains multiplied by 4 gives a score from 0 to 100, with higher scores indicating better quality of life.

  2 months

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

The intervention consisted of 5 sessions, with each lasting 100 minutes and delivered on a weekly basis.

Behavioral: Psychoeducative

Control group

PLACEBO COMPARATOR

The control group, which do not receive any psychoeducative intervention

Behavioral: Placebo

Interventions

Psychoeducative BEHAVIORAL

The intervention consiste of 5 sessions (Table 1), with each lasting 100 minutes and delivered on a weekly basis. Individual meetings will be conducted with each participant prior to starting the group work. These were considered pre-intervention sessions, during which patients provided informed consent to participate in the study and the first assessment tests were administered.

Experimental group

Placebo BEHAVIORAL

The control group, which do not receive any psychoeducative intervention

Control group

Eligibility Criteria

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

You may qualify if:

• Definite diagnosis of myositis according to the International Myositis Classification Criteria (score \> 90)
• Ability to understand the purpose and procedures of the study, and motivation and agreement to participate.

You may not qualify if:

• Do not meet the diagnostic criteria
• Patients hospitalized for an extremely severe illness
• Patients who declined to participate
• Patients who required excessive convincing for participation
• Patients who deemed likely to play a disruptive role in the group
• Patients younger than 18 years
• Patients who had severe psychiatric conditions or had an unfavorable short-term prognosis.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Barcelona, 08035, Spain

Location

Related Publications (1)

• Armadans-Tremolosa I, Palacin-Lois M, Castrechini-Trotta A, Sanduvete-Chaves S, Chacon-Moscoso S, Selva-O'Callaghan A. Effectiveness of a psychoeducational intervention on myositis patients' quality of life and well-being: a randomized controlled trial. Orphanet J Rare Dis. 2024 Nov 1;19(1):411. doi: 10.1186/s13023-024-03426-0.

  PMID: 39487522 DERIVED

MeSH Terms

Conditions

Myositis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Albert S Selva-O'Callaghan, Prof

  Vall d'Hebron General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 8, 2024
• Study Start: September 15, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)