Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers (Caregiver Career Study)

Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04603482

Enrollment

328

Registered

2020-10-26

Start date

2021-01-08

Completion date

2024-06-30

Last updated

2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Bereavement, Carer Stress Syndrome, Dementia, Stress

Keywords

Caregiver, Biofeedback, Resourcefulness, Self-Management

Brief summary

How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with Alzheimer's and other dementia disorders? Caregivers will be randomized to 1) information on diversional activities (attention control); 2) self-management intervention based on need (SM-need); or 3) self-management intervention of their preference (SM-preference).

Detailed description

The study has two aims: The primary aim (A1) is to examine differences across the three groups (attention control, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. The investigators hypothesize that the caregivers who receive a self-management intervention based on need (SM-need) or preference (SM-preference) will have better health outcomes than those in the attention control. Secondary aims are to: A2) explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/ contextual factors that are associated with their needs and preferences for the self-management interventions. All caregivers will complete assessment measures and measures of health risks, and physical and mental health at baseline (T1), about 6 months (T2), and about 12 months (T3). Caregivers will be randomly assigned to one of three groups. The attention control group will receive information on diversional activities. The SM-need group will receive a self-management intervention for biofeedback training or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the two self-management interventions according to their personal preference. Both self-management interventions (biofeedback training, resourcefulness training) and the diversional activities, are delivered over four weeks (between T1 and T2). Caregivers may use the intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. These resourcefulness training includes teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of the use of a hand-held device that shows the participant their changes in heart rate based on changes in their breathing pattern (as they relax); caregivers who need or prefer the biofeedback will be given a device to use for 28 days. All study participants receiving the intervention will also be asked to keep a journal to record their experience with the intervention.

Interventions

BEHAVIORALResourcefulness training

Resourcefulness training is a cognitive behavioral intervention that consists of teaching and reinforcing personal (self-help) and social (help-seeking) strategies to overcome adversity.

BEHAVIORALBiofeedback

Biofeedback training combines teaching slow, deep, paced breathing with real-time tracking to increase an individual's heart rate variability and ultimately improve self-regulation.

BEHAVIORALAttention Control

Participants randomly assigned to this intervention will receive suggested Diversional Activities, presented in an audiovisual format.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Participants were aware of which intervention they were receiving (Resourcefulness Training, HRV-focused BioFeedback, Attention Control: Diversonal Activities, but were not aware of which arm they had been randomly assigned to, or whether their intervention was an active or placebo comparator. The PI and Outcomes Assessor were blinded as to the identity of individual participants, and, during data collection, which participants had been assigned to which arm/intervention. In order to complete study aims, variables indicating arm and intervention assignment were included in the final data file.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* At least 18 years old * Have a living family member or a recently deceased family member diagnosed with Alzheimer's disease or another dementia * Identify self as a primary caregiver * In-home Caregivers: must be currently providing a minimum of 4 hours per day of supervision/direct care, and have entered that role within the past twelve months; Care Partners whose family member moved into a nursing or assisted living facility within the past twelve months, and must report visiting their care recipient at least once per week; Caretakers (i.e. bereaved) whose family member is deceased within the past twelve months, and are persons with direct oversight of the deceased person's belongings, estate, finances, etc. * Be capable of performing informed consent and participating in study procedures

Exclusion criteria

* Does not have a family member with Alzheimer's disease or another dementia * Has not cared for a living family member with dementia within the last 12 months, or the family member has been deceased for more than 12 months * Has knowledge of another family member in the same household enrolled in the study * Currently pregnant * Has a pacemaker * Lives outside of the study area

Design outcomes

Primary

Measure	Time frame	Description
Change in Caregiver's Perceived Stress Scale	From T1 (baseline) to T2 (6 months) through T3 (one year)	14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress
Change in Caregiver's Negative Emotions Checklist	From T1 (baseline) to T2 (6 months) through T3 (one year)	10 items; dichotomous list; Scores range 0-10; higher score indicates more negative emotions.
Change in Caregiver's Depressive Cognitions Scales	From T1 (baseline) to T2 (6 months) through T3 (one year)	8 items; 6-point scale; Scores range 0-40; higher score indicates higher depressive cognition
Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System)	From T1 (baseline) to T2 (6 months) through T3 (one year)	Change in self-assessment of general physical health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.
Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)	From T1 (baseline) to T2 (6 months) through T3 (one year)	Change in self-assessment of general mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.
Change in Caregiver's Health Risk Behavior Scale	From T1 (baseline) to T2 (6 months) through T3 (one year)	Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk

Countries

United States

Participant flow

Recruitment details

Family carers of elders with dementia will be recruited using various strategies (community support organizations, publicly posted flyers, online ads) in NE Ohio. Eligible participants were adults over the age of 18, who were carers of a family member (over the age of 65) with a medical diagnosis of dementia, and had transitioned to a new phase of caring in the previous 6 months.

Pre-assignment details

Enrolled participants may be excluded if they elect not to participate after enrolling.

Participants by arm

Arm	Count
Need Participants in this arm were, at enrollment, caregivers (in the home), care partners (with a care facility), or caretakers (bereaved) of persons with dementia. Those in this randomly assigned group were given a choice to participate in one of two self-management interventions (either biofeedback or resourcefulness training).	105
Preference Participants in this arm were, at enrollment, caregivers (in the home), care partners (with a care facility), or caretakers (bereaved) of persons with dementia. Those in this randomly assigned group were given a choice to participate in one of two self-management interventions (either biofeedback or resourcefulness training).	100
Attention Control Participants in this arm were, at enrollment, caregivers (in the home), care partners (with a care facility), or caretakers (bereaved) of persons with dementia. Those in this randomly assigned group participated in diversional activities.	103
Total	308

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	15	15	15

Baseline characteristics

Characteristic	Need	Preference	Attention Control	Total
Age, Categorical <=18 years	11 Participants	10 Participants	9 Participants	30 Participants
Age, Categorical >=65 years	38 Participants	38 Participants	39 Participants	115 Participants
Age, Categorical Between 18 and 65 years	56 Participants	52 Participants	55 Participants	163 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	3 Participants	2 Participants	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	105 Participants	97 Participants	101 Participants	303 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants	2 Participants
Race (NIH/OMB) Black or African American	20 Participants	12 Participants	16 Participants	48 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	1 Participants	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	1 Participants	3 Participants
Race (NIH/OMB) White	82 Participants	84 Participants	85 Participants	251 Participants
Region of Enrollment United States	105 participants	100 participants	103 participants	308 participants
Sex: Female, Male Female	91 Participants	87 Participants	88 Participants	266 Participants
Sex: Female, Male Male	14 Participants	13 Participants	15 Participants	42 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 105	0 / 100	0 / 103
other Total, other adverse events	0 / 105	0 / 100	0 / 103
serious Total, serious adverse events	0 / 105	0 / 100	0 / 103

Outcome results

Primary

Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)

Change in self-assessment of general mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.