Trial Outcomes & Findings for Multidisciplinary Evaluation of Patients With Hemophilia (NCT NCT02198430)

Results Overview

Measurement with Haemophilia Joint Health Score 2.1 (HJHS)

Recruitment status

COMPLETED

Target enrollment

104 participants

Primary outcome timeframe

Screening visit

Results posted on

2016-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Children without hemophilia	Patients Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
Overall Study STARTED	51	53
Overall Study COMPLETED	51	53
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multidisciplinary Evaluation of Patients With Hemophilia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients n=53 Participants Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.	Control Group n=51 Participants Children without hemophilia	Total n=104 Participants Total of all reporting groups
Age, Continuous	10.08 years STANDARD_DEVIATION 1.36 • n=93 Participants	9.78 years STANDARD_DEVIATION 1.22 • n=4 Participants	10.04 years STANDARD_DEVIATION 1.31 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	53 Participants n=93 Participants	51 Participants n=4 Participants	104 Participants n=27 Participants
Region of Enrollment Spain	53 participants n=93 Participants	51 participants n=4 Participants	104 participants n=27 Participants

PRIMARY outcome

Timeframe: Screening visit

Population: Haemophilia Joint Health Score assesses joint health in patients with hemophilia. It consists of eight dimensions: swelling, muscular atrophy, crepitation and range of motion, joint pain, strength, motion and axial alignment. The score range is from 0 to 24 points (a score of 0 indicates no joint damage. The higher the score, the higher).

Measurement with Haemophilia Joint Health Score 2.1 (HJHS)

Outcome measures

Outcome measures
Measure	Patients n=53 Participants Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.	Control Group n=51 Participants Children without hemophilia
Assess the Joint Damage	0.36 points Standard Deviation 0.84	0 points Standard Deviation 0

PRIMARY outcome

Timeframe: Screening visit

Population: The score ranges from 0 (poor QoL) to 100 points (good perception of QoL).

Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE).

Outcome measures

Outcome measures
Measure	Patients n=53 Participants Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.	Control Group n=51 Participants Children without hemophilia
Assess the Perception of Quality of Life	38.32 points Standard Deviation 4.72	37.55 points Standard Deviation 5.91

SECONDARY outcome

Timeframe: Screening visit

Hemophilia type measuring (A or B)

Outcome measures

Outcome measures
Measure	Patients n=53 Participants Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.	Control Group n=51 Participants Children without hemophilia
Assessment of Clinical Patient Variables	92.5 Percentage of Participants with Hemophil	0 Percentage of Participants with Hemophil

SECONDARY outcome

Timeframe: Screening visit (pretreatment assessment)

Measure of weight

Outcome measures

Outcome measures
Measure	Patients n=53 Participants Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.	Control Group n=51 Participants Children without hemophilia
Measure of Weight	41.59 Kg Standard Deviation 11.82	39.36 Kg Standard Deviation 9.64

Adverse Events

Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rubén Cuesta-Barriuso

Real Fundación Victoria Eugenia

Phone: +34913146508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60