Back to resultsA Chronic Disease Self Care Management Pilot Study
Primary Purpose
Chronic Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EMPOWER-BKP
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Disease
Eligibility Criteria
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. -
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Body Knowleging Program Pilot Study
Arm Description
There will be three groups of 10 participants with a chronic disease that will receive the Body knowledging Program. 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, then the intervention will be provided in seven sessions the first three face-to-face at a local community center and then the last four sessions through video conferencing that will be facilitated by three researchers. Data collection will take place at the first session and then again at the seventh session. The participants will be invited back in week nine to attend a video conference focus group to obtain qualitative data. Both qualitative and quantitative data will be analyzed.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
The Bodyknowledging Questionnaire (BKQ)
measures the phases of the Bodyknowledging program
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05622422
Brief Title
A Chronic Disease Self Care Management Pilot Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 22, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pace University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The intervention aims to activate patients' inherent resources and by this, facilitate empowerment, patient activation and self-care management of their chronic disease.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
mixed method
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Body Knowleging Program Pilot Study
Arm Type
Experimental
Arm Description
There will be three groups of 10 participants with a chronic disease that will receive the Body knowledging Program. 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, then the intervention will be provided in seven sessions the first three face-to-face at a local community center and then the last four sessions through video conferencing that will be facilitated by three researchers. Data collection will take place at the first session and then again at the seventh session. The participants will be invited back in week nine to attend a video conference focus group to obtain qualitative data. Both qualitative and quantitative data will be analyzed.
Intervention Type
Behavioral
Intervention Name(s)
EMPOWER-BKP
Intervention 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. 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.
Primary Outcome Measure Information:
Title
The Health Education Impact Questionnaire (heiQ)
Description
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.
Time Frame
15 minutes
Title
The Brief Illness Perception Questionnaire (B-IPQ)
Description
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.
Time Frame
5 minutes
Title
The Patient Activation Measure (PAM)
Description
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.
Time Frame
10 minutes
Title
The European Quality of Life Questionnaire (EQ5D)
Description
measures a person's quality of life on a scale 0-100. The higher the score the higher the quality of life.
Time Frame
10 minutes
Title
The Bodyknowledging Questionnaire (BKQ)
Description
measures the phases of the Bodyknowledging program
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie A Stepanian, Ph.D.
Phone
19147733242
Email
nstepanian@pace.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie A Stepanian, Ph.D.
Organizational Affiliation
Pace University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data will not be shared with other researchers.
Learn more about this trial
A Chronic Disease Self Care Management Pilot Study
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