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Clinical Trials/NCT05622422
NCT05622422
Not Yet Recruiting
N/A

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

Pace University0 sites30 target enrollmentSeptember 22, 2023
ConditionsChronic Disease

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Disease
Sponsor
Pace University
Enrollment
30
Primary Endpoint
The Brief Illness Perception Questionnaire (B-IPQ)
Status
Not Yet Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 22, 2023
End Date
May 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Natalie A. Stepanian Ph.D., RN

Assistant Professor

Pace University

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. -

Outcomes

Primary Outcomes

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 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 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

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