Chronic DiseaseNCT05622422
A Chronic Disease Self Care Management Pilot Study
A study testing EMPOWER-BKP in people with Chronic Disease, run by Pace University.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- EMPOWER-BKP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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. -
Trial locations and contacts
No sites are listed yet.
About this 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
The intervention aims to activate patients' inherent resources and by this, facilitate empowerment, patient activation and self-care management of their chronic disease.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- EMPOWER-BKP
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWER-BKPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Body Knowleging Program Pilot Study | Experimental | 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. Receives: Behavioral: EMPOWER-BKP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 minutes
The Bodyknowledging Questionnaire (BKQ)
measures the phases of the Bodyknowledging program
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start22 Sep 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- mixed method
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pace University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie A. Stepanian Ph.D., RN, Pace University
- Investigators
- Natalie A Stepanian, Ph.D., Principal investigator, Pace University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622422
- Sponsor's protocol ID
- 1936501-Pace
- Status last verified
- Apr 2023
- First submitted
- 14 Nov 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05622422
- Acronym / sponsor ID
- 1936501-Pace
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pace UniversityUniversity, hospital or other
- Study start
- 22 Sep 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- mixed method
| Arm | Type | Receives |
|---|---|---|
| Body Knowleging Program Pilot Study | Experimental | Behavioral: EMPOWER-BKPThere 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age
Key exclusion criteria (4 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPOWER-BKPThe 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. | Behavioural | Body Knowleging Program Pilot Study |
Primary outcome
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.
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.
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.
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.
The Bodyknowledging Questionnaire (BKQ)
Time frame: 20 minutes
measures the phases of the Bodyknowledging program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No. The individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie A Stepanian, Ph.D. principal investigator
Pace University
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER-BKP in people with Chronic Disease, run by Pace University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalie A Stepanian, Ph.D. (19147733242, nstepanian@pace.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Health Education Impact Questionnaire (heiQ) (time frame: 15 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.