Homebound Elderly People Psychotherapeutic Intervention (HEPPI)
Primary Purpose
Mild Cognitive Impairment, Depressive Symptoms, Anxiety State
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
HEPPI
Sponsored by

About this trial
This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Homebound Older Adults, Mild Cognitive Impairment, Depressive and Anxious Symptomatology, Cognitive-Emotional Intervention Program
Eligibility Criteria
Inclusion Criteria:
- Homebound older adults over 65 years old;
- Presence of aMCI;
- Presence of depressive and/or anxiety symptoms;
- Residence in mainland Portugal;
- Provision of written informed consent by participants.
Exclusion Criteria:
- Presence of a dementia diagnosis;
- Presence or history of other significant neurological conditions;
- Presence of severe psychiatric illnesses;
- Presence of comorbid medical conditions associated with cognition decline;
- Use of psychotropic medication;
- Presence of alcoholism or toxicomania;
- Significant impairment of vision, hearing, communication or manual dexterity.
Sites / Locations
- Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HEPPI program
Waiting-list control group
Arm Description
Receives access to HEPPI program at the end of the study.
Outcomes
Primary Outcome Measures
Feasibility of HEPPI program
Measured by recruitment rate
Feasibility of HEPPI program
Measured by drop-out rate
Acceptability of HEPPI program
Assessed with a questionnaire that includes questions regarding the participants' satisfaction with the program, their intention to use the program, the usefulness and relevance of the program, and its demandingness.
Secondary Outcome Measures
Changes in General Cognitive Function
Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) - Higher scores indicate a better outcome
Changes in Verbal Memory
Measured by Word List I and II (WMS-III) - Higher scores indicate a better outcome
Changes in Episodic Memory
Measured by Logical Memory I and II (WMS-III) - Higher scores indicate a better outcome
Changes in Sustained Attention
Measured by Coding-Digit Symbol (WAIS-III) - Higher scores indicate a better outcome
Changes in Depressive Symptomatology
Measured by Geriatric Depression Scale-30 (GDS-30) - Lower scores indicate a better outcome
Changes in Anxious Symptomatology
Measured by Geriatric Anxiety Inventory (GAI) - Lower scores indicate a better outcome
Changes in Subjective Memory Complaints
Measured by Subjective Memory Complaints Scale (QSM) - Lower scores indicate a better outcome
Changes in Quality of Life
Measured by World Health Organization Quality of Life-OLD Module (WHOQOL-OLD) - Higher scores indicate a better outcome
Changes in Functional Capacity
Measured by Adults and Older Adults Functional Assessment Inventory (IAFAI) - Lower scores indicate a better outcome
Full Information
NCT ID
NCT04967378
First Posted
June 19, 2021
Last Updated
June 3, 2022
Sponsor
University of Coimbra
Collaborators
Foundation for Science and Technology (FCT)
1. Study Identification
Unique Protocol Identification Number
NCT04967378
Brief Title
Homebound Elderly People Psychotherapeutic Intervention
Acronym
HEPPI
Official Title
Feasibility, Acceptability, and Preliminary Efficacy Study of a Cognitive-Emotional Intervention Program for Homebound Older Adults With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
Collaborators
Foundation for Science and Technology (FCT)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to develop, implement, and assess the feasibility, acceptability, and preliminary efficacy of a 10-week structured and individualized cognitive-emotional intervention program for homebound older adults with Mild Cognitive Impairment (MCI) and with depressive and/or anxiety symptoms. Homebound Elderly People Psychotherapeutic Intervention (HEPPI) is designed to maintain or improve memory functioning, reduce depressive and/or anxiety symptoms, and help participants to compensate or adapt to impaired cognitive performance, improving their quality of life and their subjective perception of memory and health.
Detailed Description
There is currently a significant increase in the number of homebound older adults due to multiple physical, psychological, and/or social vulnerabilities, who require in-home support services. A substantial proportion of these elderly people has MCI - more specifically amnesic MCI (aMCI) - often associated with depressive and/or anxious symptomatology. Although the general cognitive functioning and the daily functional capacity is relatively preserved, the cognitive impairment and the emotional difficulties have a significant negative impact in their quality of life.
MCI is a pathological risk condition to develop dementia, more specifically Alzheirmer's disease. Thus, a significant part of homebound older adults is in the prodromal phase of this disease, which represents a key moment for its early detection and for the application of appropriate interventions. Indeed, older adults are able to learn new information and memory strategies, as well as adapt their behavior, allowing them to benefit from such interventions.
The intervention programs focusing on cognition and MCI related symptomatology have revealed to maintain or improve the mnesic abilities and attention capacity in older people, as well as reduce depressive and/or anxiety symptoms. However, despite the growing research, there are few studies applying and assessing the effectiveness of these programs in homebound older adults. Therefore, the purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of the HEPPI program - a cognitive-emotional intervention program for homebound older adults with Mild Cognitive Impairment and with depressive and/or anxiety symptoms.
A sample of homebound older adults over 65 years old with aMCI and with depressive and/or anxiety symptoms is being recruited through contact with national entities that identify and work directly with this population, and through contact with their social support network. Participants who demonstrate interest are informed about the aims and procedures of the study, and asked to sign an informed consent form before eligibility assessment. Eligible participants are randomly assigned to either an experimental group, who receive the intervention, or a waiting-list control group, who will receive access to HEPPI program at the end of the study. Both groups complete a neuropsychological protocol to assess measures of cognition, psychological health, subjective memory complaints, quality of life, personality, and functional capacity. This protocol is applied in two different moments: at baseline (PRE) and one week after the intervention (POS1). The study procedures take place at the participants' homes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Depressive Symptoms, Anxiety State
Keywords
Homebound Older Adults, Mild Cognitive Impairment, Depressive and Anxious Symptomatology, Cognitive-Emotional Intervention Program
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HEPPI program
Arm Type
Experimental
Arm Title
Waiting-list control group
Arm Type
No Intervention
Arm Description
Receives access to HEPPI program at the end of the study.
Intervention Type
Behavioral
Intervention Name(s)
HEPPI
Other Intervention Name(s)
Homebound Elderly People Psychotherapeutic Intervention
Intervention Description
10 weekly individual sessions, 90 minutes each, at the participants' homes. The content of sessions includes psychoeducation, cognitive training, psychotherapeutic intervention, and compensatory strategy training.
Primary Outcome Measure Information:
Title
Feasibility of HEPPI program
Description
Measured by recruitment rate
Time Frame
Baseline
Title
Feasibility of HEPPI program
Description
Measured by drop-out rate
Time Frame
Immediately after the intervention
Title
Acceptability of HEPPI program
Description
Assessed with a questionnaire that includes questions regarding the participants' satisfaction with the program, their intention to use the program, the usefulness and relevance of the program, and its demandingness.
Time Frame
1 week after the intervention
Secondary Outcome Measure Information:
Title
Changes in General Cognitive Function
Description
Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) - Higher scores indicate a better outcome
Time Frame
Baseline, 1 week after the intervention
Title
Changes in Verbal Memory
Description
Measured by Word List I and II (WMS-III) - Higher scores indicate a better outcome
Time Frame
Baseline, 1 week after the intervention
Title
Changes in Episodic Memory
Description
Measured by Logical Memory I and II (WMS-III) - Higher scores indicate a better outcome
Time Frame
Baseline, 1 week after the intervention
Title
Changes in Sustained Attention
Description
Measured by Coding-Digit Symbol (WAIS-III) - Higher scores indicate a better outcome
Time Frame
Baseline, 1 week after the intervention
Title
Changes in Depressive Symptomatology
Description
Measured by Geriatric Depression Scale-30 (GDS-30) - Lower scores indicate a better outcome
Time Frame
Baseline, 1 week after the intervention
Title
Changes in Anxious Symptomatology
Description
Measured by Geriatric Anxiety Inventory (GAI) - Lower scores indicate a better outcome
Time Frame
Baseline, 1 week after the intervention
Title
Changes in Subjective Memory Complaints
Description
Measured by Subjective Memory Complaints Scale (QSM) - Lower scores indicate a better outcome
Time Frame
Baseline, 1 week after the intervention
Title
Changes in Quality of Life
Description
Measured by World Health Organization Quality of Life-OLD Module (WHOQOL-OLD) - Higher scores indicate a better outcome
Time Frame
Baseline, 1 week after the intervention
Title
Changes in Functional Capacity
Description
Measured by Adults and Older Adults Functional Assessment Inventory (IAFAI) - Lower scores indicate a better outcome
Time Frame
Baseline, 1 week after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Homebound older adults over 65 years old;
Presence of aMCI;
Presence of depressive and/or anxiety symptoms;
Residence in mainland Portugal;
Provision of written informed consent by participants.
Exclusion Criteria:
Presence of a dementia diagnosis;
Presence or history of other significant neurological conditions;
Presence of severe psychiatric illnesses;
Presence of comorbid medical conditions associated with cognition decline;
Use of psychotropic medication;
Presence of alcoholism or toxicomania;
Significant impairment of vision, hearing, communication or manual dexterity.
Facility Information:
Facility Name
Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC)
City
Coimbra
ZIP/Postal Code
3000
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Homebound Elderly People Psychotherapeutic Intervention
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