Clinical trial NCT04441060: Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities
Official title: Development of a Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illnesses
Physical Disability
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Pusan National University
First posted: 2020-06-22
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this study are developments of distress intervention and a suicidal risk scale for the patients with chronic medical illness or physical disabilities. To do these things, four times of interview \& completion of self-report scale will be done, and newly developed distress intervention will be simulated to subject group and control group.

Detailed description: The aims of this study are developments of distress intervention and a suicidal risk scale for the patients with chronic medical illness or physical disabilities.

To achieve the aims, multidisciplinary team is organized such as doctors of internal medicine, rehabilitative medicine, psychiatrist specialized in psychosomatics, psychologist, nurse, social worker and researchers.

Before developing the intervention and scale, review of literature about intervention, suicide, management system of chronic illness, several scales and others are done. Also, qualitative interview and self report scale with those patients are done to figure out what bothers them most, how they feel, and what kind of help they need.

Based on collected data, means of intervention is carefully selected and further review of literature is proceeded. Also, questions which describe patients' feeling, discomfort, and need are made. Moreover, modified management system of chronic illness is planned to develop to link between those who need help among patients and multidisciplinary team members.

Once, the intervention is developed, subject group and control group are recruited in stroke patients, and the intervention is simulated. The change of distress is measured before and after the intervention, and 1 month later the intervention is finished with several tools such as WHOQOL-BREF, Perceived Stress Scale, Rosenberg Self-Esteem Scale, Acceptance of Disability Scale, Participation Scale, Pain Belief \& Perception Inventory, Insomnia Severity Index, FACIT-Fatigue, Hospital Anxiety and Depression Scale, digit span, trail making test, stroop test, verbal fluency test.

Also, newly developed questions and other scales are performed among patients to determine whether the newly developed questions are appropriate and how well they reflect their difficulties and feelings. After selecting the appropriate questions, the revised version will be tested by the patients twice in a different time frame.

If the revised version is appraised appropriate, it will be distributed as a cell phone application.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic illness or physical disabilities (Heart failure, Chronic kidney disease, Stroke patients)

Exclusion Criteria:

* Patients who have other severe illness such as cancer, severe memory impairment or intellectual disabilities and others

Primary outcomes:
measure: Quality of life: World Health Organization's quality of life instrument -short version (WHOQOL-BREF)
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Stress: Perceived Stress Scale (PSS-10)
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Resilience: Connor-Davidson Resilience Scale (CDRS)
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Self-esteem: Rosenberg Self-Esteem Scale
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Acceptance of disability: Acceptance of Disability Scale
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Social participation: Participation Scale
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Pain: Pain belief & Perception inventory (PBPI)
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Insomnia: Insomnia Severity Index (ISI)
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Fatigue: FACIT-Fatigue
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Depression, Anxiety: Hospital Anxiety and Depression Scale
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Attention: Digit Span Test
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Attention: Trail Making Test
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Attention: Stoop Color-Word Test
timeFrame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
measure: Suicide risk : Korea-Suicide Risk Scale (the name can be changed later)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bong-Jin Hahm, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: