Trial Outcomes & Findings for Family Telemental Health Intervention for Veterans With Dementia (NCT NCT03116464)

Last Updated: 2025-06-10

Results Overview

A 31-item caregiver assessment of dementia severity, caregiver stress, and mood. Contains three patient symptom domains (Cognitive, functional, behavioral/psychological) and a caregiver quality of life domain. Shown to have good internal consistency (0.73-0.92) and construct validity.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Post Treatment, an average of 12-18 weeks

Results posted on

2025-06-10

Participant Flow

4 dyads were enrolled

Participant milestones

Participant milestones
Measure	Intervention Group Caregiver and patient with dementia dyads who receive the family intervention. Telemental Health Family Intervention: Approximately 12-16 session family intervention that will include the following specific strategies, the implementation of which will be tailored by clinicians to the specific interpersonal deficits identified in an assessment: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs
Overall Study STARTED	4
Overall Study Caregivers	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Group Caregiver and patient with dementia dyads who receive the family intervention. Telemental Health Family Intervention: Approximately 12-16 session family intervention that will include the following specific strategies, the implementation of which will be tailored by clinicians to the specific interpersonal deficits identified in an assessment: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs
Overall Study Insufficient enrollment for intervention development	4

Baseline Characteristics

The Overall Number of Baseline Participants reflects individual participants, not dyads.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=8 Participants Caregiver and patient with dementia dyads who receive the family intervention. Telemental Health Family Intervention: Approximately 12-16 session family intervention that will include the following specific strategies, the implementation of which will be tailored by clinicians to the specific interpersonal deficits identified in an assessment: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs
Age, Categorical Patients · <=18 years	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Age, Categorical Patients · Between 18 and 65 years	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Age, Categorical Patients · >=65 years	4 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Age, Categorical Caregivers · <=18 years	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Age, Categorical Caregivers · Between 18 and 65 years	1 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Age, Categorical Caregivers · >=65 years	3 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Age, Continuous Patients	75 years n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Age, Continuous Caregivers	69 years n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Sex: Female, Male Patients · Female	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Sex: Female, Male Patients · Male	4 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Sex: Female, Male Caregivers · Female	4 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Sex: Female, Male Caregivers · Male	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Ethnicity (NIH/OMB) Patients · Hispanic or Latino	2 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Ethnicity (NIH/OMB) Patients · Not Hispanic or Latino	2 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Ethnicity (NIH/OMB) Patients · Unknown or Not Reported	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Ethnicity (NIH/OMB) Caregivers · Hispanic or Latino	2 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Ethnicity (NIH/OMB) Caregivers · Not Hispanic or Latino	2 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Ethnicity (NIH/OMB) Caregivers · Unknown or Not Reported	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Patients · American Indian or Alaska Native	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Patients · Asian	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Patients · Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Patients · Black or African American	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Patients · White	2 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Patients · More than one race	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Patients · Unknown or Not Reported	2 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Caregivers · American Indian or Alaska Native	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Caregivers · Asian	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Caregivers · Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Caregivers · Black or African American	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Caregivers · White	2 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Caregivers · More than one race	0 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Race (NIH/OMB) Caregivers · Unknown or Not Reported	2 Participants n=4 Participants • The Overall Number of Baseline Participants reflects individual participants, not dyads.
Region of Enrollment United States	8 Participants n=8 Participants

PRIMARY outcome

Timeframe: Post Treatment, an average of 12-18 weeks

Population: Not applicable as due to insufficient recruitment, phase I of the project was not completed and so a treatment protocol could not be developed and implemented. No data was obtained as the intervention phase of the study did not begin.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post Treatment, an average of 12-18 weeks

A 37-item self-report scale consisting of three subscales of how well partners are able to: (1) listen and understand each other's perspectives, (2) express his or her point of view , and (3) come to a mutually satisfactory compromise. It has been shown to have high internal consistency ( = .87 to .90) and test-retest reliability (r = .62 to .92). Although developed for marital relationships, all items are applicable or easily modified for a variety of interpersonal relationships.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post Treatment, an average of 12-18 weeks

A 9-item self-report scale based on DSM-IV criteria for Major Depressive Disorder, has been shown to have good sensitivity and specificity and is predictive of health outcomes such as sick days, clinic visits, and symptom related difficulty. Internal reliability of the PHQ-9 is excellent ( = 0.89).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post Treatment, an average of 12-18 weeks

A 12-item self-report scale shown to have acceptable indices of internal consistency for the two distinct factors of the scale - personal strain and role strain ( =0.88 and =0.78) and a good predictor of caregiver mental health outcomes.

Outcome measures

Outcome data not reported

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cory K. Chen

VA New York Harbor Healthcare System

Phone: 212-686-7500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place