A Chronic Disease Self Care Management Pilot Study

Chronic Disease Clinical Trial

Official title:

A Feasibility and Pilot Study of a Person-centered and Strength-based Intervention to Facilitate Patient Empowerment, Patient Activation, Self-management, Health, and Wellness Among Adults With Chronic Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05622422
• Other study ID #: 1936501-Pace
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2023
• Source: Pace University
• Contact: Natalie A Stepanian, Ph.D.
• Phone: 19147733242
• Email: nstepanian[@]pace.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The intervention aims to activate patients' inherent resources and by this, facilitate empowerment, patient activation and self-care management of their chronic disease.

Description:

The intervention aims to activate patients' inherent resources and by this, facilitate empowerment, patient activation, and self-care management of their chronic disease. The participants will include people 18 years and older that have been diagnosed with a chronic disease. This pilot study will use a pre-post design. Data will be collected initially and then at the seventh session. The intervention will be provided in seven sessions face-to-face for the first three sessions and then via video conferencing for the last four sessions. Each session is facilitated by three researchers. Once the sessions are finished the participants will be invited to a focus session so that qualitative data can be collected in week nine.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• 18 years of age
• Undergoing treatment for chronic illness
• Cognitive capacity to participate in group formats
• Able to answer questions from questionnaires
• Able to read and speak English.
• Score greater than 18 on the MoCA cognitive test

Exclusion Criteria:

• Major reduction in cognitive capacity (i.e. major strokes, dementia, or other related conditions).
• Serious mental illness that impacts the ability to give consent or limits effective participation within a group discussion as assessed by the PI and RA in consultation following routine study protocols used in the study setting (patients may suffer from mild cognitive impairment but must be able to understand and complete questionnaires and engage in intervention groups).
• Patients in palliative phases of cancer.
• Patients in an acute medical crisis or in need of intensive care. -Patients who attend similar interventions in the same period or within the past 3 months. -

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Behavioral:
• EMPOWER-BKP
The intervention aims to activate patients' inherent resources and by this, facilitate empowerment, patient activation, and self-care management of their chronic disease. The participants will include people 18 years and older that have been diagnosed with a chronic disease. This pilot study will use a pre-post design. Some of the data will be collected initially at the first session and then again at the seventh session. The intervention will be provided in seven sessions the first three will be face-to-face at a community center and then the last four sessions will be through video conferencing and will be facilitated by three researchers. The participants will be invited to a focus group interview in week nine in order to collect quantitative data. Once the sessions are finished both qualitative and quantitative data will be collected and then analyzed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pace University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Health Education Impact Questionnaire (heiQ)	measures eight self-management skills in people with chronic conditions. Possible scores are on a 4 point likert scale. The scale is 1-4. higher score indicates better self-management, with the exception of the emotional wellbeing construct for which scoring is reversed.	15 minutes
Primary	The Brief Illness Perception Questionnaire (B-IPQ)	assesses the five cognitive illness representations on a five-point Likert scale. The scale is 0-10. A higher score reflects a more threatening view of the illness.	5 minutes
Primary	The Patient Activation Measure (PAM)	the measure of a person's knowledge, skills, and confidence to manage their own health and well-being on a 0-100 scale the higher score measures indicate higher patient activation.	10 minutes
Primary	The European Quality of Life Questionnaire (EQ5D)	measures a person's quality of life on a scale 0-100. The higher the score the higher the quality of life.	10 minutes
Primary	The Bodyknowledging Questionnaire (BKQ)	measures the phases of the Bodyknowledging program	20 minutes