HEPPI: Effectiveness of a Cognitive-Emotional Intervention for Homebound Older Adults

Sponsor

University of Coimbra (Other)

Overall Status

Recruiting

CT.gov ID

NCT05499767

Collaborator

Foundation for Science and Technology (FCT) (Other)

198

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main goal of this research is to assess the efficacy of a 10-week home-delivered cognitive-emotional intervention program for homebound older adults presenting Mild Cognitive Impairment (MCI) and depressive and/or anxiety symptoms. The Homebound Elderly People Psychotherapeutic Intervention (HEPPI) combines cognitive training, psychotherapeutic techniques, and compensatory strategy training, and was designed to optimize memory function and to reduce depressive or anxious symptomatology of these older adults.

A two-arm randomized controlled trial (RCT) is conducted to investigate the efficacy of the HEPPI among the homebound older population.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment Depressive Symptoms Anxiety State	Behavioral: HEPPI	N/A

Detailed Description

The present study aims to assess the efficacy of a cognitive-emotional intervention (the HEPPI program) for homebound older adults with MCI and depressive and/or anxious symptomatology.

The research design of the trial followed the methodological recommendations for conducting goropsychoterapy research. Moreover, a pilot RCT was conducted prior to the present RCT, in order to assess the feasibility, acceptability, and preliminary efficacy of the HEPPI. Appropriate adjustments to the HEPPI protocol were carried out considering the results.

The present study is a two-arm RCT comparing the intervention condition (HEPPI) to a wait-list control group (WLC). The sample includes community-dwelling older adults who do not leave home more often than once a week. Homebound older adults are recruited from the community through contact with their health care networks. A minimum number of 79 participants per condition will be required (N=158). Accounting for an expected 20% attrition rate, an anticipated sample of 198 participants will be enrolled in the study. Participants who demonstrate interest in the study are informed of the goals and procedures of the research and asked to provide informed consent before eligibility assessment. Eligible participants are randomly assigned to the HEPPI or the waiting-list control group.

Homebound older adults are asked to complete baseline, post-intervention, and 3-month follow-up assessments. Assessments include neuropsychological tests to assess cognition function, psychological health, subjective memory complaints, quality of life, functional status, perceived loneliness, and personality. The study procedures take place at the participants' homes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

198 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

HEPPI: A Randomized Controlled Trial of the Effectiveness of a Cognitive-Emotional Intervention for Homebound Older Adults

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HEPPI The HEPPI group attends weekly 90-minute intervention sessions at the participants' homes.	Behavioral: HEPPI Homebound Elderly People Psychotherapeutic Intervention
No Intervention: Wait-list Control Group (WLC) The WLC group receives access to HEPPI at the end of the study.

Arm

Intervention/Treatment

Experimental: HEPPI

The HEPPI group attends weekly 90-minute intervention sessions at the participants' homes.

Behavioral: HEPPI

Homebound Elderly People Psychotherapeutic Intervention

No Intervention: Wait-list Control Group (WLC)

The WLC group receives access to HEPPI at the end of the study.

Outcome Measures

Primary Outcome Measures

Changes in Episodic Memory [Baseline, 1 week post-intervention, 3-month follow-up]
Logical Memory of the Wechsler Memory Scale-III (LM) | Higher scores indicate a better outcome
Changes in Depressive Symptomatology [Baseline, 1 week post-intervention, 3-month follow-up]
Measured by Geriatric Depression Scale-30 (GDS-30) | Lower scores indicate a better outcome
Changes in Anxious Symptomatology [Baseline, 1 week post-intervention, 3-month follow-up]
Measured by Geriatric Anxiety Inventory (GAI) | Lower scores indicate a better outcome

Secondary Outcome Measures

Changes in General Cognitive Function [Baseline, 1 week post-intervention, 3-month follow-up]
Measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) | Higher scores indicate a better outcome
Changes in Attentional Control [Baseline, 1 week post-intervention, 3-month follow-up]
Measured by Digit Symbol-Coding of the Wechsler Adult Intelligence Scale-III (DSC) | Higher scores indicate a better outcome
Changes in Subjective Memory Complaints [Baseline, 1 week post-intervention, 3-month follow-up]
Measured by Subjective Memory Complaints Scale (SMCS) | Lower scores indicate a better outcome
Changes in Perceived Quality of Life [Baseline, 1 week post-intervention, 3-month follow-up]
Measured by European Portuguese World Health Organization Quality of Life-Old Module (WHOQOL-OLD) | Higher scores indicate a better outcome
Changes in Functional Status [Baseline, 1 week post-intervention, 3-month follow-up]
Measured by Adults and Older Adults Functional Assessment Inventory (IAFAI) | Lower scores indicate a better outcome
Changes in Loneliness [Baseline, 1 week post-intervention, 3-month follow-up]
Measured by UCLA Loneliness Scale (UCLA) | Lower scores indicate a better outcome

Other Outcome Measures

Personality Traits [Baseline]
Measured by NEO Five-Factor Inventory (NEO-FFI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Homebound older adults aged 65 years and older;
MoCA score 1 to 1.5 standard deviation below the mean for age- and education- adjusted norms;
FCSRT total immediate and delayed recall scores ≤ 35 and ≤ 12, respectively;
Presence of subjective memory complaints (SMCS score ≥ 3);
Presence of depressive symptomatology (GDS-30 score ≥ 11);
Presence of anxious symptomatology (GAI score ≥ 8);
No significant impact from cognitive impairment on daily functional capacity;
Residence in mainland Portugal;