A Chronic Disease Self Care Management Pilot Study (EMPOWER-BKP)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: EMPOWER-BKP

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalie A Stepanian, Ph.D.; Phone Number: 19147733242; Email: nstepanian@pace.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Body Knowleging Program Pilot Study; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
The Bodyknowledging Questionnaire (BKQ)	measures the phases of the Bodyknowledging program	20 minutes

Collaborators and Investigators

• Sponsor: Pace University
• Investigators: Principal Investigator: Natalie A Stepanian, Ph.D., Pace University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 22, 2023
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 1936501-Pace

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No