A Chronic Disease Self Care Management Pilot Study

NCT05622422 | Unknown

• 1 other identifier: 1936501-Pace
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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.

Behavioral: EMPOWER-BKP

Interventions

EMPOWER-BKP BEHAVIORAL

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.

Body Knowleging Program Pilot Study

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Pace University: lead

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Natalie A Stepanian, Ph.D.

  Pace University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie A Stepanian, Ph.D.

CONTACT

19147733242; nstepanian@pace.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: mixed method

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 18, 2022
• Study Start: September 22, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share