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

April 27, 2023 updated by: Natalie A. Stepanian Ph.D., RN, Pace University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Health Education Impact Questionnaire (heiQ)
Time Frame: 15 minutes
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)
Time Frame: 5 minutes
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)
Time Frame: 10 minutes
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)
Time Frame: 10 minutes
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)
Time Frame: 20 minutes
measures the phases of the Bodyknowledging program
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pace University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natalie A Stepanian, Ph.D., Pace University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings