Quality of Life and the Effects of Tailored Health Coaching in Fibromyalgia Patients

NCT04100538 | Completed

• 1 other identifier: N201809035
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aims:

1. 1.To identify phenotypes of patients with fibromyalgia according to symptom clusters and to compare differences in quality of life (QOL) among different phenotypes.
2. 2.To examine the effects of technology-assisted and tailored health coaching in comparison to telephone support on health status, QOL, pain catastrophizing, and self-efficacy in patients with fibromyalgia.

Conditions

Fibromyalgia

Keywords

Health coaching; Quality of Life

Outcome Measures

Primary Outcomes (6)

• Fibromyalgia Impact Questionnaire (FIQR) at baseline

  The FIQR is an instrument that assesses the current health status of patients with fibromyalgia in clinical and research settings; it comprised three domains: physical function, overall effect of fibromyalgia, and fibromyalgia symptoms (pain, fatigue, un refreshing sleep, stiffness, anxiety, depression, tenderness to touch, memory, balance and environmental sensitivity). All 21 questions are graded on a 0-10 numeric scale (no difficulty to very difficult); higher FIQR score indicates greater symptom severity. The reliability coefficients ranged from 0.56 on the pain score to 0.95 for physical function. A Chinese version of the FIQR will be used.

  baseline

• Fibromyalgia Impact Questionnaire (FIQR) after the 10 weeks of training period

  The FIQR is an instrument that assesses the current health status of patients with fibromyalgia in clinical and research settings; it comprised three domains: physical function, overall effect of fibromyalgia, and fibromyalgia symptoms (pain, fatigue, un refreshing sleep, stiffness, anxiety, depression, tenderness to touch, memory, balance and environmental sensitivity). All 21 questions are graded on a 0-10 numeric scale (no difficulty to very difficult); higher FIQR score indicates greater symptom severity. The reliability coefficients ranged from 0.56 on the pain score to 0.95 for physical function. A Chinese version of the FIQR will be used.

  after the 10 weeks of training period

• Fibromyalgia Impact Questionnaire (FIQR) at 3 months postintervention

  The FIQR is an instrument that assesses the current health status of patients with fibromyalgia in clinical and research settings; it comprised three domains: physical function, overall effect of fibromyalgia, and fibromyalgia symptoms (pain, fatigue, un refreshing sleep, stiffness, anxiety, depression, tenderness to touch, memory, balance and environmental sensitivity). All 21 questions are graded on a 0-10 numeric scale (no difficulty to very difficult); higher FIQR score indicates greater symptom severity. The reliability coefficients ranged from 0.56 on the pain score to 0.95 for physical function. A Chinese version of the FIQR will be used.

  3 months postintervention

• World Health Organization Quality of Life - BREF (WHOQOL-BREF) at baseline

  This study will use the WHOQOL-BREF to determine participants' overall QOL. The WHOQOL-BREF was developed by World Health Organization (WHO)76, which is a brief self-report instrument to measure subjects' overall quality of life. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The Taiwan version of WHOQOL-BREF which contains 28 items has a Cronbach's α for internal consistency of 0.70 to 0.77.

  baseline

• World Health Organization Quality of Life - BREF (WHOQOL-BREF) after the 10 weeks of training period

  This study will use the WHOQOL-BREF to determine participants' overall QOL. The WHOQOL-BREF was developed by World Health Organization (WHO)76, which is a brief self-report instrument to measure subjects' overall quality of life. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The Taiwan version of WHOQOL-BREF which contains 28 items has a Cronbach's α for internal consistency of 0.70 to 0.77.

  after the 10 weeks of training period

• World Health Organization Quality of Life - BREF (WHOQOL-BREF) at 3 months postintervention

  This study will use the WHOQOL-BREF to determine participants' overall QOL. The WHOQOL-BREF was developed by World Health Organization (WHO)76, which is a brief self-report instrument to measure subjects' overall quality of life. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The Taiwan version of WHOQOL-BREF which contains 28 items has a Cronbach's α for internal consistency of 0.70 to 0.77.

  3 months postintervention

Secondary Outcomes (4)

• Beck Depression Inventory-II (BDI-II)

  baseline,after the 10 weeks of training period (posttest 1), and at 3 months postintervention (posttest 2)

• Beck Anxiety Inventory (BAI)

  baseline, after the 10 weeks of training period (posttest 1), and at 3 months postintervention (posttest 2)

• Pain Catastrophizing Scale (PCS)

  baseline, after the 10 weeks of training period (posttest 1), and at 3 months postintervention (posttest 2)

• Pain Self-Efficacy Questionnaire (PSEQ)

  baseline, after the 10 weeks of training period (posttest 1), and at 3 months postintervention (posttest 2)

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive the technology-assisted program by health coach twice a week during the 10-week treatment period. The health coach will be an experienced master-prepared nurse who has extensive and in-depth knowledge about fibromyalgia and has previously worked in direct contact with patients with fibromyalgia in a research project.

Behavioral: health coach

control group

NO INTERVENTION

The control group will receive technology-assisted informational support twice a week during the 10-week treatment period. Each technology-assisted informational support will last for approximately 10-30 min consisting of 15-min questions-and-answers regarding the educational materials and 15-min debriefing.

Interventions

health coach BEHAVIORAL

The health-coaching program includes (1) my file, (2) lesson, (3) self-assessment, and (4) interaction modules. My file allows participants recording their disease history. The lesson includes knowledge of fibromyalgia, stress and relaxation, emotion and positive thinking, sleep hygiene, communication skills, and exercise. The self-assessments includes symptom diary, exercise and general diary. The interaction encourages participants interacting with peers and the health coach. Participants can share practical advices, strategies, real-life examples or questions via texts or photos in "share garden". Participants can connect to the health coach via "contact with health coach". The coach will provide comments or responses approximately 10-30 min for each time. The coach will monitor each participant's lesson list and attendance for each lesson. The health coach will also guide the participants to create their own tailored programs according to participants' predominant symptom subtypes.

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older.
• A Polysymptomatic Distress Scale (PDS) score of 13 and greater.

You may not qualify if:

• Study2.
• years of age and older.
• A Polysymptomatic Distress Scale (PDS) score of 13 and greater.
• Capable of using web-application via smartphone.
• Medical history of significant head injury or neurological disorder.
• Malignant neoplasm.
• Women with pregnancy.

Sponsors & Collaborators

• Taipei Medical University: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Bio-Behavior Research Laboratory

Taipei, Taiwan

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Pei-Shan Tsai, PhD

  Taipei Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bio-Behavior Research Laboratory

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 24, 2019
• Study Start: July 15, 2019
• Primary Completion: November 19, 2021
• Study Completion: November 6, 2022
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)