Clinical trial NCT05622422: A Chronic Disease Self Care Management Pilot 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Lead sponsor: Pace University
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: mixed method
Primary purpose: PREVENTION

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.

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. -

Primary outcomes:
measure: The Health Education Impact Questionnaire (heiQ)
timeFrame: 15 minutes
measure: The Brief Illness Perception Questionnaire (B-IPQ)
timeFrame: 5 minutes
measure: The Patient Activation Measure (PAM)
timeFrame: 10 minutes
measure: The European Quality of Life Questionnaire (EQ5D)
timeFrame: 10 minutes
measure: The Bodyknowledging Questionnaire (BKQ)
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pace University
name: Natalie A Stepanian, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: