A Chronic Disease Self Care Management Pilot Study

Not Applicable

Not yet recruiting

• Conditions: Chronic Disease

• Registration Number: NCT05622422
• Lead Sponsor: Pace University

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.

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-18
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28
• Study Start: 2023-09-22
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The Brief Illness Perception Questionnaire (B-IPQ)	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)	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)	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)	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)	20 minutes	measures the phases of the Bodyknowledging program