Trial Outcomes & Findings for DEMA-Pro Intervention for Seniors With Subjective Cognitive Decline and Living at Home (NCT NCT04796415)

Last Updated: 2023-10-18

Results Overview

Change in Physical Function measured by the Outcome and Assessment Information Set Data of Instructive Activities of Daily Living Scale (OASIS-D, IADLs Scale M1800s ).The ADL/IADL composite score ranges from 0 (total independence) to 9 (totally dependent/unable to complete). Higher score represent greater dependence.

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

Baseline to 6 weeks

Results posted on

2023-10-18

Participant Flow

Patient enrollment is reported because patients were the pre-specified participants. Feedback about the intervention was collected from staff, but staff were not participants.

Participant milestones

Participant milestones
Measure	DEMA-Pro The DEMA-Pro intervention will be administrated. Subjects will attend six weekly, 1-hour telephone sessions. the DEMA-Pro intervention: Trained DEMA-Pro coaches will deliver six weekly, 1-hour telephone sessions. The first session is an orientation to the DEMA-Pro intervention and development of the initial Weekly Activity Plan based on the patient's self-identified meaningful activity. Over the next five weekly sessions, the coach uses problem-solving strategies to facilitate dyad collaboration to mutually identify meaningful activities and make a realist plan to achieve the patient-identified meaning activity goals. In each session, the patient and caregiver also select, review, and discuss one of six topics in the Self-Management Toolkit (e.g., planning meaningful activities; learning strategies for living with subjective cognitive impairment; finding resources, planning for the future).
Overall Study STARTED	49
Overall Study Session #1	35
Overall Study Session #2	25
Overall Study Session #3	21
Overall Study Session #4	19
Overall Study Session #5	19
Overall Study Session #6	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	DEMA-Pro The DEMA-Pro intervention will be administrated. Subjects will attend six weekly, 1-hour telephone sessions. the DEMA-Pro intervention: Trained DEMA-Pro coaches will deliver six weekly, 1-hour telephone sessions. The first session is an orientation to the DEMA-Pro intervention and development of the initial Weekly Activity Plan based on the patient's self-identified meaningful activity. Over the next five weekly sessions, the coach uses problem-solving strategies to facilitate dyad collaboration to mutually identify meaningful activities and make a realist plan to achieve the patient-identified meaning activity goals. In each session, the patient and caregiver also select, review, and discuss one of six topics in the Self-Management Toolkit (e.g., planning meaningful activities; learning strategies for living with subjective cognitive impairment; finding resources, planning for the future).
Overall Study not interested	12
Overall Study health issue	8
Overall Study Other	4
Overall Study discharged from home health service	3
Overall Study re-hospitalization	2
Overall Study moving to nursing home	1
Overall Study lost contact	1

Baseline Characteristics

DEMA-Pro Intervention for Seniors With Subjective Cognitive Decline and Living at Home

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DEMA-Pro n=49 Participants The DEMA-Pro intervention will be administrated. Subjects will attend six weekly, 1-hour telephone sessions. the DEMA-Pro intervention: Trained DEMA-Pro coaches will deliver six weekly, 1-hour telephone sessions. The first session is an orientation to the DEMA-Pro intervention and development of the initial Weekly Activity Plan based on the patient's self-identified meaningful activity. Over the next five weekly sessions, the coach uses problem-solving strategies to facilitate dyad collaboration to mutually identify meaningful activities and make a realist plan to achieve the patient-identified meaning activity goals. In each session, the patient and caregiver also select, review, and discuss one of six topics in the Self-Management Toolkit (e.g., planning meaningful activities; learning strategies for living with subjective cognitive impairment; finding resources, planning for the future).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	44 Participants n=5 Participants
Age, Continuous Mean Age	78.5 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants
Primary Diagnosis Diabetes	21 Participants n=5 Participants
Primary Diagnosis Cardiovascular related	33 Participants n=5 Participants
Primary Diagnosis Primary Diagnosis related to fracture, surgery and post-surgery care	16 Participants n=5 Participants
Primary Diagnosis Participants with hospitalization risks	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 weeks

Population: 14/18 completed OASIS-D ADLs Scale at start of care (pre- intervention) and when discharged from Home Health Agency(post-intervention) in this Pilot Phase of pragmatic trial.

Outcome measures

Outcome measures
Measure	DEMA-Pro n=14 Participants The DEMA-Pro intervention will be administered. Subjects will attend six weekly, 1-hour telephone sessions. the DEMA-Pro intervention: Trained DEMA-Pro coaches will deliver six weekly, 1-hour telephone sessions. The first session is an orientation to the DEMA-Pro intervention and development of the initial Weekly Activity Plan based on the patient's self-identified meaningful activity. Over the next five weekly sessions, the coach uses problem-solving strategies to facilitate dyad collaboration to mutually identify meaningful activities and make a realist plan to achieve the patient-identified meaning activity goals. In each session, the patient and caregiver also select, review, and discuss one of six topics in the Self-Management Toolkit (e.g., planning meaningful activities; learning strategies for living with subjective cognitive impairment; finding resources, planning for the future).
Physical Function	-4.7 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days

Population: 18 participants psychosocial well-being measures was collected by Home Health Agency Call Center Staff at pre and post DEMA-Pro program..

Psychosocial Well-being-Short-Form.The Psychosocial well-being short form composes 12 items and ranges from 12 to 60. Higher scores represent better quality of life.Change in the mean score and standard deviation was calculated from pre and post DEMA-Pro intervention. 1-5 Likert Scale. 1= not at all, 5= very much or strongly agree

Outcome measures

Outcome measures
Measure	DEMA-Pro n=18 Participants The DEMA-Pro intervention will be administered. Subjects will attend six weekly, 1-hour telephone sessions. the DEMA-Pro intervention: Trained DEMA-Pro coaches will deliver six weekly, 1-hour telephone sessions. The first session is an orientation to the DEMA-Pro intervention and development of the initial Weekly Activity Plan based on the patient's self-identified meaningful activity. Over the next five weekly sessions, the coach uses problem-solving strategies to facilitate dyad collaboration to mutually identify meaningful activities and make a realist plan to achieve the patient-identified meaning activity goals. In each session, the patient and caregiver also select, review, and discuss one of six topics in the Self-Management Toolkit (e.g., planning meaningful activities; learning strategies for living with subjective cognitive impairment; finding resources, planning for the future).
Sense of Well-Being	7.7 score on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: 1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days

Population: The OASIS PHQ-2 was not collected because the current version of OASIS-D does not have PHQ-2 subscale.

OASIS-D sub data of PHQ-2 (M1730); The current version of OASIS does not have PhQ-2 items so we did not ask the coach to collect the PHQ-2 data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year after completing the intervention

Population: Outcome data collection was not funded for this measure, data were not collected

OASIS-D sub data of Frequency of rehospitalization rate (M2410)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year after completing the intervention

Population: Outcome data collection was not funded for this measure, so data were not collected.

OASIS-D sub data of Frequency unplanned urgent care or hospital ER care (M2301, M2041)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year after intervention

Population: .Outcome data collection was not funded for this measure, so data were not collected.

OASIS-D sub data of Frequency of transfers to nursing home care (M2410)

Outcome measures

Outcome data not reported

Adverse Events

DEMA-Pro

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DEMA-Pro n=49 participants at risk The DEMA-Pro intervention will be administrated. Subjects will attend six weekly, 1-hour telephone sessions. the DEMA-Pro intervention: Trained DEMA-Pro coaches will deliver six weekly, 1-hour telephone sessions. The first session is an orientation to the DEMA-Pro intervention and development of the initial Weekly Activity Plan based on the patient's self-identified meaningful activity. Over the next five weekly sessions, the coach uses problem-solving strategies to facilitate dyad collaboration to mutually identify meaningful activities and make a realist plan to achieve the patient-identified meaning activity goals. In each session, the patient and caregiver also select, review, and discuss one of six topics in the Self-Management Toolkit (e.g., planning meaningful activities; learning strategies for living with subjective cognitive impairment; finding resources, planning for the future).
Vascular disorders Visited ED due to fall and fracture of 2 ribs	2.0% 1/49 • Number of events 1 • 1 year 3 months Adverse events for patients, who were the pre-specified participants, are included. Adverse events were not collected or reported for staff.
Cardiac disorders Hospitalization	2.0% 1/49 • Number of events 1 • 1 year 3 months Adverse events for patients, who were the pre-specified participants, are included. Adverse events were not collected or reported for staff.
Vascular disorders Visited ED due to high blood pressure 228/119	2.0% 1/49 • Number of events 1 • 1 year 3 months Adverse events for patients, who were the pre-specified participants, are included. Adverse events were not collected or reported for staff.
Cardiac disorders Hospitalization due to CHF	2.0% 1/49 • Number of events 1 • 1 year 3 months Adverse events for patients, who were the pre-specified participants, are included. Adverse events were not collected or reported for staff.

Other adverse events

Other adverse events
Measure	DEMA-Pro n=49 participants at risk The DEMA-Pro intervention will be administrated. Subjects will attend six weekly, 1-hour telephone sessions. the DEMA-Pro intervention: Trained DEMA-Pro coaches will deliver six weekly, 1-hour telephone sessions. The first session is an orientation to the DEMA-Pro intervention and development of the initial Weekly Activity Plan based on the patient's self-identified meaningful activity. Over the next five weekly sessions, the coach uses problem-solving strategies to facilitate dyad collaboration to mutually identify meaningful activities and make a realist plan to achieve the patient-identified meaning activity goals. In each session, the patient and caregiver also select, review, and discuss one of six topics in the Self-Management Toolkit (e.g., planning meaningful activities; learning strategies for living with subjective cognitive impairment; finding resources, planning for the future).
General disorders Fall without injury	6.1% 3/49 • Number of events 3 • 1 year 3 months Adverse events for patients, who were the pre-specified participants, are included. Adverse events were not collected or reported for staff.

Additional Information

Yvonne Lu, PhD, RN, FGSA, FAAN, Professor, Science of Nursing Care Department

Indiana University School of Nursing

Phone: 3172782042

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place