Brief Summary

Hypertension is an risk factor for cognitive impairment. The primary objective of this study is to evaluate the efficacy of 12-week computerized cognitive training in people with hypertension and mild cognitive impairment. The researchers will further investigate the long-term effects of cognitive training by prolonging the intervention for 24 weeks among a randomly selected sub-group.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

200

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach

1 country

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

January 9, 2023

Completed

21 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed

2 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed

Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 9, 2023

Last Update Submit

January 20, 2023

Conditions

Mild Cognitive Impairment Hypertension

Keywords

Cognitive trainingDigital healthHypertension

Outcome Measures

Primary Outcomes (1)

Global cognitive function change measured by BCAT in 12 weeks
The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function measured by Basic Cognitive Ability Test (BCAT). BCAT is a set of neuropsychological battery tests which was designed to measure global cognitive fucntion and cognitive function of sub-domains. Higher scores of BCAT means a better global cognitive function.
12 weeks after randomization

Secondary Outcomes (7)

Global cognitive function change measured by BCAT in 24 weeks
24 weeks after randomization
Sub-domain cognitive function improvement including memory, attention, and execution memory
12 weeks, 24 weeks after randomization
Cognitive score change
12 weeks, 24 weeks after randomization
Self-efficacy score
12 weeks, 24 weeks after randomization
Quality of life score
12 weeks, 24 weeks after randomization
+2 more secondary outcomes

Study Arms (2)

Adaptive cognitive training

EXPERIMENTAL

This arm is the intervention arm. Participants randomized to this arm will use a tablet to receive the multi-domain adaptive cognitive training, which will be delivered 30 minutes at least 5 times a week for 12 weeks.

Behavioral: Multi-domain adaptive cognitive training

Active control

ACTIVE COMPARATOR

This arm is the control arm. Participants randomized to this arm will use the same tablet to receive the cognitive training of low difficulty level with no adaptive change. The intervention dosage will be the same, which is 30 minutes each time, at least 5 times a week for 12 weeks.

Behavioral: Basic cognitive training with no difficulty change

Interventions

Multi-domain adaptive cognitive trainingBEHAVIORAL

The multi-domain adaptive cognitive training covers seven aspects of fundamental cognitive function, including sensory perception, cognitive flexibility, attention, memory, language, logic calculation, and emotion recognition and management. A self-adaptive algorithm is embedded in the tablet-based cognitive training platform, which will help deliver suitable tasks at the right difficulty level for each participant according to their personal profile and real-time performance. The intervention dosage is 30 minutes per time, 5 times a week.

Adaptive cognitive training

Basic cognitive training with no difficulty changeBEHAVIORAL

The basic cognitive training for the control arm will also be delivered via a tablet. The training tasks will be fixed at a primary difficulty level without adaptive algorithm. The intervention dosage is also 30 minutes per time, 5 times a week.

Active control

Eligibility Criteria

Age60 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Older than 60 years;
Completed 6 or more years of education;
Untreated or under treatment hypertension;
Complaint of memory decline within 1 year;
Global cognitive score measured by the Montreal Cognitive Assessment is below 26;
Agree to receive cognitive function evaluation, randomization, and follow-up investigation as required;

You may not qualify if:

Unable to complete cognitive function evaluation due to vision, hearing, and other problems;
Have been diagnosed of dementia or MMSE score ≤ 20;
Unable to use the cognitive training equipment after 2 times instructions;
Alcohol abuse or taking drugs that could affect cognitive function (antihistamines, antipsychotics);
Diabetes patients;
Moderate to severe decrease in glomerular filtration rate (eGFR\<30 ml/min /1.73m2);
Systolic blood pressure ≥180 mmHg or/and diastolic blood pressure ≥110 mmHg; or orthostatic hypotension (defined as the third standing SBP\<100mmHg);
History of cardiovascular events or hospitalization due to cardiovascular diseases in the last 3 months;
Planned to receive coronary intervention, atrial fibrillation ablation or cardiac surgery within 6 months; or have received these intervention strategies in the last 3 months;
Symptomatic heart failure or left ventricular ejection fraction \<50%；
Atrial fibrillation confirmed by ECG with marked and severe onset of symptoms;
A history of stroke, or head injury in the last 6 months; past history of brain tumor or neurosurgery;
Past history of Parkinson's disease, Alzheimer's disease, schizophrenia, and epilepsy;
Have Ever undergone surgery under general anesthesia in the last three months;
Severe hepatic impairment or in critical condition patients with very poor prognosis whose expected survival is less than 6 months; or diagnosed of malignant tumor other than non-melanoma skin cancer in the last 2 years;
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Beijing Anzhen Hospitallead
Beijing Wispirit Technology Co., Ltdcollaborator

Study Sites (2)

Beijing Anzhen Hospital

Beijing, China

Location

Ruijing Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Related Publications (1)

Kong Y, Guo QH, Zhou L, He L, Zeng Y, Du X, Dong JZ, Jiang C, Wang JG, Ma CS. Digital computerised cognitive training for preventing cognitive decline among hypertensive patients: a study protocol for a multicentre randomised controlled trial (DELIGHT trial). BMJ Open. 2024 Feb 29;14(2):e079305. doi: 10.1136/bmjopen-2023-079305.
PMID: 38423771DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionHypertension

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersVascular DiseasesCardiovascular Diseases

Study Officials

Chang sheng Ma
Beijing Anzhen Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Kong

CONTACT

086-13811901076 ky5166@126.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 30, 2023

Study Start

February 1, 2023

Primary Completion

December 31, 2024

Study Completion

March 30, 2025

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing: Will not share

Locations

CN(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Adaptive cognitive training

Active control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations